Donor Stem Cell Transplant or Donor White Blood Cell Infu... | NCT00281879

NCT00281879

Status Module

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Detailed Description

OBJECTIVES:

Primary

Determine the effectiveness of unrelated donor allogeneic hematopoietic stem cells for transplantation after conditioning for the treatment of patients with high-risk hematologic malignancies.
Compare survival, disease-free survival (DFS), response rate, and toxicity rates in these patients with historical controls.
Compare the rate and severity of acute and chronic GVHD after allogeneic hematopoietic stem cell transplantation in patients with hematopoietic malignancies with historical controls transplanted with stem cells from related sibling donors
Assess engraftment, long-term hematopoietic recovery, relapse rate, and disease-free survival when allogeneic hematopoietic stem cells are used as a source of stem cells for transplantation in patients with high-risk hematological malignancies.
Assess engraftment, long-term hematopoietic recovery, and overall survival when allogeneic hematopoietic stem cells are used as a source of stem cells for transplantation in patients who have graft failure or graft rejection.
Compare engraftment, long-term hematopoietic recovery, rate of GVHD, rate of relapse, toxicity rates, overall disease-free survival and overall survival when donor leukocyte infusions (DLI) are given for patients who have disease recurrence, progression, or low donor chimerisms after unrelated stem cell transplantation or before DLI with historical controls of other donor leukocyte infusions.

Secondary

Determine the quality of life of patients undergoing hematopoietic stem cell transplantation or donor leukocyte infusions from unrelated HLA genotypically-identical donors.

OUTLINE: Patients are assigned to 1 of 8 treatment groups.

Group 1*: Patients undergo total body irradiation (TBI) twice a day on days -7 to -4. Patients then receive cyclophosphamide IV over 1 hour on days -3 and -2. On day 0 patients undergo stem cell transplantation (SCT). Beginning on day 7, patients receive filgrastim (G-CSF) IV once daily until blood counts recover.
Group 2 (patients who have previously experienced dose-limiting radiotherapy): Patients receive oral busulfan 4 times daily on days -7 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2. On day 0 patients undergo SCT. Beginning on day 7, patients receive G-CSF IV once daily until blood counts recover.
Group 3 (pediatric patients only): Patients receive busulfan IV 4 times daily on days -9 to -6 and cyclophosphamide IV over 1 hour and fludarabine IV over 30 minutes on days -5 to -2. On day 0 patients undergo SCT. Beginning on day 7, patients may receive G-CSF IV once daily until blood counts recover.
Group 4 (second SCT for patients who have experienced graft rejection or failure)*: Patients receive low-dose fludarabine IV over 30 minutes on days -4 to -2. Patients then undergo low-dose TBI once followed by SCT on day 0. Beginning on day 7, patients may receive G-CSF IV once daily until blood counts recover.
Group 5 (patients who developed grade 3 cystitis after prior cyclophosphamide-containing therapy): Patients receive carmustine IV over 2 hours on day -6, etoposide IV over 2 hours and cytarabine IV over 30 minutes on days -5 to -2, and melphalan IV over 30 minutes on day -1 (BEAM). On day 0, patients undergo SCT. Beginning on day 7, patients receive G-CSF IV once daily until blood counts recover.
Group 6 (cord blood transplantation): Patients receive anti-thymocyte globulin IV once daily and methylprednisolone IV twice daily on days -3 to -1. On day 0, patients undergo an umbilical cord blood SCT.
Group 7 (patients with relapsing or progressive disease after prior transplants or low donor chimerisms)*: Patients must not have existing graft-versus-host disease (GVHD). Patients receive donor lymphocyte infusions with conditioning chemotherapy and/or radiotherapy at the discretion of the investigator.
Group 8 (pediatric patients only)*: Patients undergo TBI twice a day on days -7 to -5. Patients also receive etoposide IV over 24 hours on day -4 and cyclophosphamide IV over 1 hour on days -3 and -2. On day 0, patients undergo SCT. Beginning on day 7, patients may receive G-CSF IV once daily until blood counts recover.

NOTE: *Patients who have received > 3000 cGy to the central nervous system or > 2000 cGy to the lung or liver may not receive any regimen containing total body irradiation (TBI)

All patients receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11; cyclosporine and/or tacrolimus on days -2 to 100; and/or methylprednisolone IV on days 7 to 100.

Patients with an unrelated donor who experience a relapse prior to transplantation, may proceed directly to transplantation. However, if immediate transplantation from the unrelated donor is not possible, the patient must be re-induced into a complete hematological remission. Patients who experience graft failure or graft rejection after allogeneic transplantation are eligible for a second stem cell infusion from the original donor.

Quality of life is assessed at baseline and at 7 days, 3 months, and 1 year after transplantation.

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)	Active Comparator		Biological: filgrastim Drug: cyclophosphamide Drug: cyclosporine Drug: methotrexate Drug: mycophenolate mofetil Drug: tacrolimus Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy
Busulfan and Cyclophosphamide (Cytoxan)	Active Comparator		Biological: filgrastim Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: methotrexate Drug: mycophenolate mofetil Drug: tacrolimus Procedure: peripheral blood stem cell transplantation
BEAM Regimen	Active Comparator	On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).	Biological: filgrastim Drug: carmustine Drug: cyclosporine Drug: cytarabine Drug: etoposide Drug: melphalan Drug: methotrexate Drug: mycophenolate mofetil Drug: tacrolimus Procedure: peripheral blood stem cell transplantation
Low-Dose Fludarabine and TBI(for second stem cell donation)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
anti-thymocyte globulin	Biological	Intravenous, 1.5 mg/kg of body weight daily for 7 to 14 days The first dose should be administered over a minimum of 6 hours and over at least 4 hours on subsequent doses through a high-flow vein.

Measure	Description	Time Frame
Number of Participants With Disease Free Survival (DFS).	Determine the effectiveness of unrelated donor allogeneic hematopoietic stem cells for transplantation after conditioning for the treatment of high-risk hematopoietic malignancies. Disease-free survival: The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer.	Duration of the study; Up to 2 years

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of 1 of the following*:
- Acute lymphoblastic leukemia in any disease phase
  - Patients with any of the following high-risk features are encouraged to enroll:
    - Philadelphia chromosome positive disease
    - L3 morphology, especially in the presence of t(8;14), t(8;22), or t(2;8)
    - Patients not in remission at day 28 of first induction
    - High LDH (i.e., ≥ 300 IU/mL at presentation)
    - Pre-B-cell, mixed lineage, or Burkitt's markers
    - Relapsed in the marrow while receiving continuous chemotherapy
    - Within 6 months after stopping chemotherapy
    - Relapse in one organ or extramedullary relapses in more than one organ while still receiving chemotherapy
- Hodgkin's or non-Hodgkin's lymphoma beyond first complete remission (CR) or in first CR with features of high-risk disease, including, but not limited to:
  - Lymphoma not in CR after 3 courses of primary therapy
  - Patients with bulky disease at presentation, especially bulky mediastinal disease
  - Patients with LDH ≥ 300 IU/mL at presentation
  - Patients with extranodal disease
  - Patients with first remission within less than 1 year
  - Stage IV disease at presentation, especially with marrow involvement
  - Patients with high-intermediate or high International Index Scores
- Acute myeloid leukemia (AML) meeting the following criteria:
  - Beyond first remission or high-risk disease in first CR
  - Required multiple courses of induction therapy to achieve a remission
  - Had residual leukemia on day 14-28 bone marrow examination after initial induction
  - Patients with any cytogenetic abnormality except inv 16 or t(8;21)
- Chronic myelogenous leukemia in the chronic or early accelerated phase of the disease
  - Patients with blast crisis that can be induced back into chronic phase may be transplanted in second chronic phase
- Myelodysplastic syndromes (MDS) meeting the following requirements:
  - Transfusion-dependent refractory anemia (RA), RA with excess blasts (RAEB), RAEB in transformation, or chronic myelomonocytic leukemia (CMML)
  - Patients with MDS that present with or evolve to AML must be re-induced back to remission prior to initiating a search for an unrelated donor NOTE: *Patients with other hematologic malignancies not listed above, including diseases such as chronic lymphocytic leukemia (CLL), multiple myeloma, or rare pediatric malignancies, or patients who are felt to be at high-risk for relapse but who do not have features listed, may be allowed at the discretion of the investigator.
Must have failed prior stem cell transplantation
Must have a suitable unrelated allogeneic hematopoietic stem cell donor
- A 5/6 match degree is acceptable for unrelated bone marrow donors
- A 4/6 match degree is acceptable for unrelated cord blood units

PATIENT CHARACTERISTICS:

SWOG performance status (PS) 0-2 OR
Karnofsky PS 50-100% OR
Lansky PS 50-100%
Creatinine clearance ≥ 45 mL/min
Creatinine ≤ 2.5 mg/dL
Bilirubin ≤ 2 mg/dL (abnormally high liver function tests allowed if the only source for the elevation is due to lymphoma of the liver)
AST or ALT ≤ 2 times normal (abnormally high liver function tests allowed if the only source for the elevation is due to lymphoma of the liver)
No patients at high risk of veno-occlusive disease
Not pregnant or nursing
Negative serum pregnancy test
Fertile patients must use an effective contraceptive method
DLCO ≥ 50% of predicted
FEV_1/FVC ≥ 65% of predicted
No current congestive heart failure (CHF) and/or LVEF ≥ 45%
No myocardial infarction within the past 6 months
No unstable angina within the past 6 months
HIV negative
Life expectancy must not be limited by disease other than malignancy
No allergy to any chemotherapeutic agent included in the regimen

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

Name	Affiliation	Role
Richard Maziarz, MD	OHSU Knight Cancer Institute	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
OHSU Knight Cancer Institute		Portland	Oregon	97239-3098	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)	On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)	On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
BG001	Busulfan and Cyclophosphamide (Cytoxan)	On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
BG002	BEAM Regimen	On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
BG003	Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)	A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
BG004	Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)	On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
BG005	ATG For Cord Blood Transplants	If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
BG006	DLI (Donor Leukocyte Infusion)	Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.
BG007	Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)	On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor's cells.
BG008	Total	Total of all reporting groups

Units	Counts
Participants	BG000128 BG00136 BG00220 BG0030 BG0046 BG0059 BG0060 BG0071 BG008200

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Disease Free Survival (DFS).

Determine the effectiveness of unrelated donor allogeneic hematopoietic stem cells for transplantation after conditioning for the treatment of high-risk hematopoietic malignancies.

Disease-free survival: The length of time after treatment ends that a patient survives without any signs or symptoms of that cancer or any other type of cancer.

Posted

Duration of the study; Up to 2 years

ID	Title	Description
OG000	Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)
OG001	Busulfan and Cyclophosphamide (Cytoxan)
OG002	BEAM Regimen	On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
OG003	Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)	A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
OG004	Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)	On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
OG005	ATG For Cord Blood Transplants	If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
OG006	DLI (Donor Leukocyte Infusion)	Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.
OG007	Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)	On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor's cells.

Units	Counts
Participants	OG0000 OG0010 OG0020 OG003

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)	On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.	101	128	19	128
EG001	Busulfan and Cyclophosphamide (Cytoxan)	On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).	25	36	0	36
EG002	BEAM Regimen	On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).	17	20	2	20
EG003	Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)	A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.	0	0	0	0
EG004	Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)	On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.	5	6	0	6
EG005	ATG For Cord Blood Transplants	If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.	6	9	0	9
EG006	DLI (Donor Leukocyte Infusion)	Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.	0	0	0	0
EG007	Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)	On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor's cells.	1	1	0	1

Serious Adverse Events

Term	Organ System	Statistical Information
Staph Sepsis	Blood and lymphatic system disorders	EG0003 affected128 at risk EG0011 affected36 at risk EG0020 affected20 at risk EG0030 events0 affected0 at risk EG0040 affected6 at risk EG0050 affected9 at risk EG0060 events0 affected0 at risk EG0070 events0 affected1 at risk
Altered mental status	Psychiatric disorders	EG0001 affected128 at risk EG0011 affected36 at risk EG0020 affected20 at risk EG003
Pneumonia	Respiratory, thoracic and mediastinal disorders	EG0005 affected128 at risk EG0011 affected36 at risk EG0020 affected20 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	EG0001 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Death	General disorders	EG000101 affected128 at risk EG00125 affected36 at risk EG00217 affected20 at risk EG003
Fever	Immune system disorders	EG0000 affected128 at risk EG0010 affected36 at risk EG0021 affected20 at risk EG003
Graft versus host disease (GVHD)	Gastrointestinal disorders	EG00017 affected128 at risk EG00113 affected36 at risk EG0023 affected20 at risk EG003
Acute Respiratory Distress Syndrome (ARDS)	Respiratory, thoracic and mediastinal disorders	EG0003 affected128 at risk EG0012 affected36 at risk EG0022 affected20 at risk EG003
Cardiac Problems	Cardiac disorders	EG0001 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	EG0001 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Diarrhea	General disorders	EG0004 affected128 at risk EG0012 affected36 at risk EG0020 affected20 at risk EG003
Orthostatic Hypertension	Blood and lymphatic system disorders	EG0003 affected128 at risk EG0011 affected36 at risk EG0020 affected20 at risk EG003
acute renal failure	Renal and urinary disorders	EG0001 affected128 at risk EG0011 affected36 at risk EG0021 affected20 at risk EG003
Intraparenchymal Hemorrhage	Vascular disorders	EG0001 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Pulmonary Hemorrhage	Respiratory, thoracic and mediastinal disorders	EG0002 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Rigors	Immune system disorders	EG0003 affected128 at risk EG0012 affected36 at risk EG0020 affected20 at risk EG003
Pneutropenic Fever	Immune system disorders	EG0003 affected128 at risk EG0012 affected36 at risk EG0020 affected20 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	EG0001 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Kidney Stones	Renal and urinary disorders	EG0000 affected128 at risk EG0013 affected36 at risk EG0022 affected20 at risk EG003
Encephalopathy	Infections and infestations	EG0001 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Viral encephalitis	Infections and infestations	EG0001 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Pulmonary aspergillus	Respiratory, thoracic and mediastinal disorders	EG0001 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Avascular necrosis	Musculoskeletal and connective tissue disorders	EG0001 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Anorexia	Psychiatric disorders	EG0001 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Dehydration	General disorders	EG0003 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Alveolar hemorrhage	Respiratory, thoracic and mediastinal disorders	EG00015 affected128 at risk EG0013 affected36 at risk EG0022 affected20 at risk EG003
Bronchopneumonia	Respiratory, thoracic and mediastinal disorders	EG0004 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Bacterial pneumonia	Respiratory, thoracic and mediastinal disorders	EG0001 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Seizures	General disorders	EG0002 affected128 at risk EG0011 affected36 at risk EG0020 affected20 at risk EG003
Cytomegalovirus pneumonitis	Respiratory, thoracic and mediastinal disorders	EG0003 affected128 at risk EG0010 affected36 at risk EG0021 affected20 at risk EG003
Tachycardia	Cardiac disorders	EG0001 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Positive blood cultures	Blood and lymphatic system disorders	EG0002 affected128 at risk EG0011 affected36 at risk EG0020 affected20 at risk EG003
Gastroenteritis	Gastrointestinal disorders	EG0002 affected128 at risk EG0011 affected36 at risk EG0020 affected20 at risk EG003
Liver failure	Hepatobiliary disorders	EG0001 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Hyperbilirubinemia	Hepatobiliary disorders	EG0001 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003
Fungal infection	Infections and infestations	EG00011 affected128 at risk EG0012 affected36 at risk EG0022 affected20 at risk EG003
Steroid-induced psychoses	Psychiatric disorders	EG0001 affected128 at risk EG0010 affected36 at risk EG0020 events0 affected20 at risk EG003

ID	Term
D009196	Myeloproliferative Disorders
D007938	Leukemia
D008223	Lymphoma
D009101	Multiple Myeloma
D054219	Neoplasms, Plasma Cell
D009190	Myelodysplastic Syndromes
D054437	Myelodysplastic-Myeloproliferative Diseases
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D015465	Leukemia, Myeloid, Accelerated Phase
D001752	Blast Crisis
D015466	Leukemia, Myeloid, Chronic-Phase
D006689	Hodgkin Disease
D012008	Recurrence
D000013	Congenital Abnormalities
D015470	Leukemia, Myeloid, Acute
D000754	Anemia, Refractory, with Excess of Blasts
D000753	Anemia, Refractory
D015477	Leukemia, Myelomonocytic, Chronic
C580364	Pdgfra-Associated Chronic Eosinophilic Leukemia
D055728	Primary Myelofibrosis
D015467	Leukemia, Neutrophilic, Chronic
D054438	Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
D054429	Leukemia, Myelomonocytic, Juvenile
D018442	Lymphoma, B-Cell, Marginal Zone
D002051	Burkitt Lymphoma
D016403	Lymphoma, Large B-Cell, Diffuse
D008228	Lymphoma, Non-Hodgkin
D016400	Lymphoma, Large-Cell, Immunoblastic
D054739	Dendritic Cell Sarcoma, Interdigitating
D008224	Lymphoma, Follicular
D020522	Lymphoma, Mantle-Cell
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D007943	Leukemia, Hairy Cell

Ancestor Terms

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010265	Paraproteinemias
D001796	Blood Protein Disorders
D006474	Hemorrhagic Disorders
D007945	Leukemia, Lymphoid
D015464	Leukemia, Myelogenous, Chronic, BCR-ABL Positive
D007951	Leukemia, Myeloid
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D002471	Cell Transformation, Neoplastic
D063646	Carcinogenesis
D009385	Neoplastic Processes
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D000740	Anemia
D016393	Lymphoma, B-Cell
D020031	Epstein-Barr Virus Infections
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections
D014412	Tumor Virus Infections
D015620	Histiocytic Disorders, Malignant
D015614	Histiocytosis
D015448	Leukemia, B-Cell

Ancestor Terms

ID	Term
D007106	Immune Sera
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
D001688	Biological Products
D045424	Complex Mixtures
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D001685	Biological Factors
D002072	Butylene Glycols
D006018	Glycols
D000438	Alcohols
D009930	Organic Chemicals
D008698	Mesylates
D000476	Alkanesulfonates
D017738	Alkanesulfonic Acids
D000473	Alkanes
D006839	Hydrocarbons, Acyclic
D006838	Hydrocarbons
D013451	Sulfonic Acids
D013456	Sulfur Acids
D013457	Sulfur Compounds
D009607	Nitrosourea Compounds
D014508	Urea
D000577	Amides
D009603	Nitroso Compounds
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated
D063088	Phosphoramides
D009943	Organophosphorus Compounds
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001087	Arabinonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D005960	Glucosides
D006027	Glycosides
D010649	Phenylalanine
D024322	Amino Acids, Aromatic
D000598	Amino Acids, Cyclic
D000596	Amino Acids
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D011239	Prednisolone
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D005227	Fatty Acids
D008055	Lipids
D018942	Macrolides
D007783	Lactones
D018380	Hematopoietic Stem Cell Transplantation
D033581	Stem Cell Transplantation
D017690	Cell Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics
D014180	Transplantation
D013514	Surgical Procedures, Operative

ID	Type	Link
P30CA016058	U.S. NIH Grant/Contract	View source
OHSU-TPI-9695-L
OHSU-540

ID	Term
D000961	Antilymphocyte Serum
D000069585	Filgrastim
D016179	Granulocyte Colony-Stimulating Factor
D002066	Busulfan
D002330	Carmustine
D003520	Cyclophosphamide
D016572	Cyclosporine
D003561	Cytarabine
D005047	Etoposide
C042382	fludarabine phosphate
D008558	Melphalan
D008727	Methotrexate
D008775	Methylprednisolone
D009173	Mycophenolic Acid
D016559	Tacrolimus
D036102	Peripheral Blood Stem Cell Transplantation
D036101	Cord Blood Stem Cell Transplantation
D011878	Radiotherapy

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Headache	General disorders				EG0008 affected128 at risk EG0010 affected36 at risk EG0022 affected20 at risk EG0030 events0 affected0 at risk EG0040 events0 affected6 at risk EG0050 events0 affected9 at risk EG0060 events0 affected0 at risk EG0070 events0 affected1 at risk
Nausea	General disorders				EG00011 affected128 at risk EG0010 affected36 at risk EG0020 affected20 at risk EG003