Clinical trial · Interventional
Donor Bone Marrow Transplant in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
Allogeneic Bone Marrow Transplantation Using Closely Matched Related and Unrelated Donors
- 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: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the stem cells from a related or unrelated donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow to make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in treating patients with leukemia, lymphoma, or nonmalignant hematologic disorders.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Malignant Plasma Cell Neoplasms | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| TBI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cy/TBI
- description
- cyclophosphamide and total body irradiation (TBI)
- interventionNames
- Drug: cyclophosphamide
- Radiation: TBI
Primary outcomes (1)
- measure
- event free survival (EFS)
- timeFrame
- five year post transplant
- description
- EFS determined by the Kaplan-Meier product limit method
Secondary outcomes (1)
- measure
- Incidence of graft versus host disease
- timeFrame
- five years post transplant
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 50 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of one of the following:
* Acute lymphocytic leukemia (ALL):
* Complete remission (CR) 1 - high risk defined as overt CNS involvement or poor cytogenetics (additions, deletions, translocations, or multiple abnormalities)
* CR2
* Induction failures
* Relapse - patients with at least 10% marrow blasts undergo at least one reinduction attempt
* Acute myelogenous leukemia (AML):
* CR1 - high risk defined as poor cytogenetics (deletions, additions, multiple abnormalities)
* CR2
* Induction failures
* Relapse - patients with at least 10% marrow blasts undergo at least one reinduction attempt
* Chronic myelogenous leukemia (CML):
* Chronic phase (CP) 1
* Accelerated phase/CP2 - patients in blast phase must undergo treatment and achieve a second chronic phase prior to transplant
* Chronic lymphocytic leukemia (CLL):
* Relapse - any stage; must have received no more than 3 prior regimens
* Multiple myeloma:
* At diagnosis - primary refractory
* Relapse (no more than 2) - sensitive disease
* Plasma cell leukemia
* Inability to achieve a complete remission after autologous transplant (no older than 40)
* Myelodysplasia - all subtypes
* Myeloproliferative disorders - patients with poor response to medical therapy or cytogenetic abnormalities
* Severe aplastic anemia (SAA):
* Very SAA - at diagnosis
* SAA - induction therapy
* Donors must be a phenotypic (6 out of 6) match or a one antigen (A or B) mismatch
PATIENT CHARACTERISTICS:
Age:
* 15 to 50
Performance status:
* Karnofsky 80-100%
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* SGOT and SGPT no greater than 3 times normal
* PT/PTT normal
Renal:
* Creatinine no greater than 2.0 mg/dL
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* Left ventricular ejection fraction at least 45%
* No myocardial infarction within past 6 months
* No uncontrolled arrhythmias
Pulmonary:
* FEV1 at least 50%
* DLCO at least 50% predicted
Other:
* No active serious infection
* HIV negative
* Not pregnant or nursing
* No uncontrolled diabetes mellitus or thyroid disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specifiedReferences
Publications (0)
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