Clinical trial · Interventional
Treatment of Bone Marrow to Prevent Graft-Versus-Host Disease in Patients With Acute or Chronic Leukemia Undergoing Bone Marrow Transplantation
A Multi-Center, Open Label, Randomized, Active Controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Processed Unrelated Bone Marrow in Patients With Acute or Chronic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Bone marrow that has been treated to remove certain white blood cells may reduce the chance of developing graft-versus-host disease following bone marrow transplantation. PURPOSE: Randomized phase II/III trial to compare the effectiveness of treated bone marrow with that of untreated bone marrow in preventing graft-versus-host disease in patients with acute or chronic leukemia who are undergoing bone marrow transplantation.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic bone marrow transplantation | Procedure | — | UNRESOLVED |
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| in vitro-treated bone marrow transplantation | Procedure | — | UNRESOLVED |
| methylprednisolone | Drug | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 50 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of one of the following:
* Acute myelogenous leukemia (AML) or acute lymphocytic leukemia (ALL) in first early relapse, second remission, or subsequent remission
* AML in first complete remission with one of the following adverse features:
* Antecedent hematologic disorder such as myelodysplasia
* AML resulting from prior chemotherapy or radiotherapy
* More than 1 course of induction chemotherapy to achieve remission or adverse cytogenetics such as Philadelphia chromosome 9:22, +8, +11; abnormal 12p; or deletions of chromosomes 5, 7, or 20 (3:3)
* ALL in first complete remission with poor risk cytogenetics such as
* Philadelphia chromosome 9:22, 8:14, or 4:11 OR
* WBC greater than 100,000/mm3 OR
* Time to achieve complete remission more than 4 weeks
* Chronic myelogenous leukemia in chronic or accelerated phase
* Myelodysplastic syndromes
* Refractory anemia with excess blasts (RAEB) OR
* RAEB in transformation
* Unrelated bone marrow donor available
* If matched at 6 of 6 HLA-A, -B, and -DR loci, patient must be 12 to 50 years
* If matched at 5 of 6 loci, patient must be 12 to 35 years
* No matched sibling donor available
* No uncontrolled CNS leukemia
PATIENT CHARACTERISTICS:
Age:
* See Disease Characteristics
* 12 to 50
Performance status:
* Karnofsky 70-100%
Life expectancy:
* At least 12 weeks
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Bilirubin less than 2.5 times upper limit of normal (ULN)
* SGOT or SGPT less than 2.5 times ULN
Renal:
* Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* LVEF greater than 50% without medication
Pulmonary:
* DLCO and FVC at least 50% predicted
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other serious medical illness
* No uncontrolled diabetes mellitus
* No uncontrolled and/or active infection
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 3 weeks since prior immunotherapy and recovered
* At least 1 year since prior autologous transplantation
* No prior allogeneic transplantation
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy (except hydroxyurea) and recovered
Endocrine therapy:
* At least 3 weeks since prior hormonal therapy and recovered
Radiotherapy:
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered
* No prior radiotherapy at doses that would preclude study
Surgery:
* Not specifiedReferences
Publications (0)
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