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| ID | Type | Description | Link |
|---|---|---|---|
| UCI 21-90 | Other Identifier | UCI CFCCC |
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This is a prospective, single-arm, phase II study. Patients will be treated with an allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on patient- and disease-related risk.
Eligible patients will receive an allogeneic stem cell transplantation using a combination of fludarabine, melphalan and total body irradiation (TBI) conditioning regimen and post-transplant high dose cyclophosphamide (PTCY), tacrolimus and mycophenolate mofetil (MMF) for graft-versus-host prophylaxis.
Melphalan and TBI doses will be tailored based on the Hematopoietic Stem Cell Transplant- Composite Risk (HCT-CR), age and Karnofski performance status (KPS). Melphalan dose ranges from 100 -140 mg/m2 while TBI dose ranges from 2-5 Gy.
All patients will be monitored for safety and efficacy up to 2 years post-transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT | Experimental | Patients will be treated with allogeneic stem cell transplantation (AHSCT) using fludarabine, melphalan and total body irradiation (TBI) conditioning with different melphalan and TBI doses based on their Hematopoietic Cell Transplant - Composite Risk (HCT-CR), age, and Karnofski performance status (KPS). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine | Drug | Given Day-5, Day-4, Day-3, Day-2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | PFS is defined as the time from stem cell infusion to time of disease relapse or death from any cause; data for patients who were alive without relapse will be censored at the date of last contact. | Up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS is defined as the time from stem cell infusion until death from any cause. Data of patients who were alive without relapse will be censored at the date of last contact. | Up to 48 months |
| Cumulative incidence of Graft-Versus-Host-Free, relapse-free survival (GRFS) |
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Inclusion Criteria:
Male or female aged 18-70 years
Diagnosis of AML, ALL, MDS, CML, NHL, HD, CLL requiring AHSCT
Has an HLA-matched related (MRD), HLA-matched unrelated (MUD), haploidentical (HAPLO) or 1-Ag mismatched unrelated donor (MMUD)
Karnofsky performance >70%
Adequate major organ system function as demonstrated by:
Ability to understand and the willingness to sign a written informed consent. a. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center University of California, Irvine | Contact | 1-877-827-8839 | ucstudy@uci.edu | |
| University of California Irvine Medical | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Stefan O. Ciurea, MD | Chao Family Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center, University of California Irvine | Recruiting | Orange | California | 92868 | United States |
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| Melphalan | Drug | Given Day-5 |
|
| Total Body Irradiation | Radiation | Given Day-1 |
|
|
GRFS is defined as time from stem cell infusion to time of the first event among acute GVHD grades 3-4, extensive chronic GVHD, relapse, and death. Data of patients who are event-free will be censored at the date of last contact. |
| Up to 48 months |
| Cumulative incidence of relapse | Relapse is defined as re-occurrence of the disease after stem cell infusion. Cumulative incidence of relapse will be measured from date of stem cell infusion to date of disease relapse. Death without disease relapse is considered a competing risk for relapse. Data of patients who are alive without disease relapse will be censored at the date of last contact. | Up to 48 months |
| Cumulative incidence of Non-Relapse Mortality (NRM) | NRM is defined as death related to AHSCT during continuous complete remission. Cumulative incidence of NRM will be measured from date of stem cell infusion to date of death. Disease relapse is considered a competing risk for NRM. Data of patients who are alive without disease relapse will be censored at the date of last contact. | Up to 48 months |
| Cumulative incidence of acute and chronic graft versus host disease (GVHD) | Acute and chronic GVHD will be measured from date of stem cell infusion to date of the event. Death without GVHD is considered a competing risk for GVHD. Patients who are alive without GVHD will be censored at the date of last contact. | Up to 48 months |
| Area Under the Curve (AUC) of Melphalan | AUC will be used to determine the pharmacokinetic of melphalan after the infusion on D-5. Data will be summarized using descriptive statistics. | From melphalan infusion start time to 22 hours after the infusion. |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D008558 | Melphalan |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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