Clinical trial · Interventional
Safety Study of Bone Marrow Transplant Using Mismatched Tissue Followed by Chemotherapy
A Phase II Trial of Myeloablative Conditioning and Transplantation of Partially HLA-mismatched Bone Marrow for Patients With Hematologic Malignancies
NCT00796562CI-TRIAL-00037606completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to see if giving high dose chemotherapy and total body irradiation before and repeating high dose chemotherapy after a bone marrow transplant could reduce the incidence of graft rejection and disease for patients with blood cancers
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 |
|---|---|---|---|
| Leukemias | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphomas | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| MDS | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Total body irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Myeloablative haploidentical BMT
- description
- * All participants except those with acute lymphoblastic leukemia and lymphoblastic lymphoma: Busulfan will be administered 1 mg/kg oral (or 0.8 mg/kg IV) four times per day for four days, followed by cyclophosphamide 50 mg/kg once per day for two days. * Participants with acute lymphocytic leukemia or lymphoblastic lymphoma: Cyclophosphamide will be administered 50 mg/kg once per day for two days, followed by total body irradiation at 300 cGy per day for four days.
- interventionNames
- Drug: Busulfan
- Drug: Cyclophosphamide
- Radiation: Total body irradiation
Primary outcomes (1)
- measure
- Engraftment as Measured by Donor Chimerism
- timeFrame
- Day 60
- description
- Percentage of participants who achieved donor chimerism \>=95%.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Acute lymphocytic leukemia in high risk CR1 * Acute myeloid leukemia in CR1 * Therapy-related AML * RAEB with \>5% and \<20% bone marrow blasts * Chronic myelogenous leukemia beyond 1st chronic phase; Patients cannot be in blast crisis * CMMoL * JMML * Chemotherapy-resistant Hodgkins Lymphoma or intermediate or high grade Non-Hodgkins lymphoma (Less than a PR after standard or salvage chemotherapy) * Mantle cell lymphoma: chemotherapy refractory (Less than a PR after standard or salvage chemotherapy) or patients beyond CR1 with chemosensitive disease * Follicular Lymphoma, Grade 3 * Transformed indolent lymphomas Exclusion Criteria: * Poor cardiac function: left ventricular ejection fraction \<45% as determined by MUGA or ECHO. For pediatric patients LVEF \<45% or a shortening fraction below normal limits for age. * Poor pulmonary function: FEV1 and FVC \<50% predicted for patients who have not received thoracic or mantle irradiation. For patients who have received thoracic or mantle irradiation, FEV1 and FVC \<70% predicted or DLCO \< 50 of predicted. For children unable to perform PFTs because of developmental stage pulse oximetry \< 85% on RA * Poor liver function: bilirubin \>2 mg/dl (not due to hemolysis, Gilbert's or primary malignancy) * Poor renal function: Creatinine \>2.0mg/dl or creatinine clearance * HIV-positive * Positive leukocytotoxic crossmatch * Women of childbearing potential who currently are pregnant or who are not practicing adequate contraception * Uncontrolled viral, bacterial, or fungal infections Patients with symptoms consistent with RSV, influenza A, B, or parainfluenza at the time of enrollment will be assayed for the above viruses and if positive are not eligible for the trial until they are no longer symptomatic (patients may have continued assay positivity for a period of time post resolution of symptoms secondary to the nature of the assay. * Indolent lymphomas (Follicular Grade 1 and 2, marginal zone, chronic lymphocytic leukemia, small lymphocytic lymphoma, MALT)
References
Publications (2)
- BACKGROUNDFine J.P. and Gray, R.J. (1999), A proportional hazards model for the subdistribution of a competing risk, Journal of the American Statistical Association, 94:496-509.
- DERIVEDSymons HJ, Zahurak M, Cao Y, Chen A, Cooke K, Gamper C, Klein O, Llosa N, Zambidis ET, Ambinder R, Bolanos-Meade J, Borrello I, Brodsky R, DeZern A, Gojo I, Showel M, Swinnen L, Smith BD, Luznik L, Jones RJ, Fuchs EJ. Myeloablative haploidentical BMT with posttransplant cyclophosphamide for hematologic malignancies in children and adults. Blood Adv. 2020 Aug 25;4(16):3913-3925. doi: 10.1182/bloodadvances.2020001648. PMID 32813874