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| ID | Type | Description | Link |
|---|---|---|---|
| 288263 | Other Identifier | UC Davis | |
| UCD-196 | Other Identifier | UCDCC |
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Giving chemotherapy drugs, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects of giving donor peripheral stem cell transplant together with fludarabine and busulfan and to see how well it works in treating patients with hematologic cancers.
OUTLINE:
Patients with recurrent disease or < 100% donor T-cell chimerism (on day 30) undergo a 12-day CSA and MMF taper followed by escalating doses of previously collected donor leukocyte infusion every 4 weeks until 100% donor T-cell chimerism or disease regression, in the absence of ≥ grade 2 GVHD.
After completion of study treatment, patients are followed periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIST for Heme malignancies | Other | Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| busulfan | Drug |
| ||
| cyclosporine |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Day 100 Transplant-related Mortality | Patients were followed for death and whether or not that death was attributed to the day 100 transplant via physician assessment for 24 months after day 100 transplant. | 24 months after day 100 transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Without Progression After Day 100 Transplant | All patients will be followed for progression for 24 months after their day 100 transplant. | 24 months after day 100 transplant |
| Number of Patients Alive 24 Months Post Day 100 Transplant |
Not provided
DISEASE CHARACTERISTICS:
Diagnosed with any of the following:
Acute myeloid leukemia (AML), meeting 1 of the following criteria:
Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:
Chronic myelogenous leukemia (CML), meeting the following criteria:
First or second chronic phase
Chronic lymphocytic leukemia (CLL), meeting the following criteria:
Recurrent disease after fludarabine-based therapy
Recurrent Hodgkin lymphoma, recurrent non-Hodgkin lymphoma (NHL) (low-, intermediate-, or high-grade disease*), or transformed NHL, meeting 1 of the following criteria:
Recurrent multiple myeloma, meeting the following criteria:
Myelodysplastic syndrome
Refractory anemia (RA)/RA with ringed sideroblasts (RARS), refractory cytopenia with multilineage dysplasia (RCMD)/refractory cytopenia with multilineage dysplasia with ringed sideroblasts (RCMD-RS), or RA with excess blasts (RAEB) I, meeting the following criteria:
No uncontrolled CNS metastases
5-6/6 HLA-matched sibling or 9-10/10 matched unrelated donor (both patient and donor) available
PATIENT CHARACTERISTICS:
Karnofsky performance status ≥ 50%
Serum creatinine ≤ 2 mg/dL
Not pregnant
Fertile patients must use effective contraception
50 years of age or older
Patients 18-50 years of age are eligible if meeting 1 of the following criteria:
Must be willing to accept or comprehend irreversible sterility as a side effect of therapy
No uncontrolled active infection
No psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible
Cardiac ejection fraction ≥ 30%
Corrected pulmonary-diffusing capacity ≥ 35%
No serologic evidence of infection with HIV
No decompensated liver disease with serum bilirubin > 2.0 mg/dL
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Carol M. Richman, MD | University of California, Davis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Cancer Center | Sacramento | California | 95817 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | RIST for Heme Malignancies | Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy busulfan cyclosporine fludarabine phosphate mycophenolate mofetil allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| fludarabine phosphate | Drug |
|
| mycophenolate mofetil | Drug |
|
| allogeneic hematopoietic stem cell transplantation | Procedure |
|
| peripheral blood stem cell transplantation | Procedure |
|
Patients will be followed for survival for 24 months post day 100 transplant. |
| 24 months post day 100 transplant |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RIST for Heme Malignancies | Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy busulfan cyclosporine fludarabine phosphate mycophenolate mofetil allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 Patients With Day 100 Transplant-related Mortality | Patients were followed for death and whether or not that death was attributed to the day 100 transplant via physician assessment for 24 months after day 100 transplant. | Posted | Count of Participants | Participants | 24 months after day 100 transplant |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Patients Without Progression After Day 100 Transplant | All patients will be followed for progression for 24 months after their day 100 transplant. | This outcome was not collected/analyzed | Posted | 24 months after day 100 transplant |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Patients Alive 24 Months Post Day 100 Transplant | Patients will be followed for survival for 24 months post day 100 transplant. | Posted | Count of Participants | Participants | 24 months post day 100 transplant |
|
|
Adverse events were collected through Day 100 of treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RIST for Heme Malignancies | Busulfan 3.3 mg/kg over 3 hours on day -6 and day -5 Fludarabine 30 mg/m2 IV over 30 minutes on day -6 to day -2 followed by Transplant followed by Immunosuppressive/GVHD therapy busulfan cyclosporine fludarabine phosphate mycophenolate mofetil allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation | 0 | 8 | 8 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| blood bicarbonate decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritic rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Duodenal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: head and neck | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: trunk/genital | General disorders | CTCAE (3.0) | Systematic Assessment | Left breast |
|
| esophageal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Eye disorder | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue-lower mobility | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperbilirubinemia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Small lesions |
|
| Mucositis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Myalgia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Myelitis | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Oral hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-lower extremity | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Petechia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Rash NOS | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash desuamating | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste alteration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
|
This study was closed after only enrolling 8 patients and results were never published.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Data Manager | University of California Davis | 916-734-8381 | nmahaffey@ucdavis.edu |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D009190 | Myelodysplastic Syndromes |
| D015470 | Leukemia, Myeloid, Acute |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D000753 | Anemia, Refractory |
| D000013 | Congenital Abnormalities |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D006689 | Hodgkin Disease |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008224 | Lymphoma, Follicular |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| 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 |
| D001855 | Bone Marrow Diseases |
| D007951 | Leukemia, Myeloid |
| D000740 | Anemia |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| 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 |
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| ID | Term |
|---|---|
| D002066 | Busulfan |
| D016572 | Cyclosporine |
| C042382 | fludarabine phosphate |
| D009173 | Mycophenolic Acid |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| 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 |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| 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 |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|