Clinical trial · Interventional
Nonmyeloablative Allogeneic Transplant
Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using Antithymocyte Globulin With Either Melphalan and Cladribine or Total Lymphoid Irradiation
NCT01272817CI-TRIAL-00062321Mini-allocompletedN/AClinicalTrials.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)
Allogeneic transplant from a matched sibling for the treatment of a variety of illnesses including bone marrow failure states, leukemias, myelodysplastic or myeloproliferative syndromes, lymphoma, or myeloma using a nonmyeloablative preparative regimen.
Conditions
Conditions (18)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Aplastic Anemia | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hodgkin's Lymphoma | Hodgkin Lymphoma | ALIAS | 0.90 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nonmyeloablative Allogeneic Transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Cladribine + melphalan
- description
- Cladribine + melphalan conditioning
- interventionNames
- Procedure: Nonmyeloablative Allogeneic Transplant
- type
- OTHER
- label
- TLI
- description
- Total lymphoid irradiation conditioning
- interventionNames
- Procedure: Nonmyeloablative Allogeneic Transplant
Primary outcomes (1)
- measure
- Engraftment
- timeFrame
- One year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 72 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \> 55 years or 2. Age \< 55 and LVEF \< 45% or creatinine clearance \< 60 ml/min 3. Ability to cover the cost of the transplant, necessary medications, and transportation/housing. 4. Caregiver must be available while outpatient Guidelines for Cladribine-Melphalan-based conditioning: * Bone Marrow Failure States Severe Aplastic Anemia (relapsed following immunosuppressive therapy) Paroxysmal Nocturnal Hemoglobinuria (poor prognostic features or hemosiderosis) * AML (first CR except for t(15;17), inv16, t(8,21); second CR; relapse failing second induction attempt) * ALL (first CR with at least one poor prognostic feature; second or greater CR; relapse failing reinduction attempt) * MDS (RAEB, RAEBiT, CMMoL) * CML (chronic phase; accelerated phase; blast phase following reinduction attempt; 2nd chronic or accelerated phase following gleevec therapy * Hodgkin's lymphoma (first or greater relapse) * Non-Hodgkin's Lymphoma * Aggressive Histology (includes T Cell NHL) Incomplete response to induction Second CR Sensitive or refractory relapse * Indolent Histology Second or greater relapse * Mantle Cell Lymphoma (any Stage - must have received induction chemotherapy) * Multiple Myeloma (10% residual plasmacytosis following anthracycline-based chemotherapy or residual disease following autologous transplant) * Waldenstrom Macroglobulinemia (must have failed either purine analogue-based chemotherapy (Fludara or 2CdA) or standard CVP therapy; hyperviscosity or cytopenias) Guidelines for total lymphoid irradiation-based conditioning * MDS (RA, RARS) * CLL (Rai stage III or IV - must have received at least two different treatment regimens in the past) * Breast Cancer (symptomatic metastatic disease, who have failed standard chemotherapy) * Renal Cell Cancer (metastatic disease at multiple sites) * Malignant Melanoma (metastatic disease at multiple sites) * Sarcoma (all subtypes presently, unresectable metastatic disease) * Ovarian Cancer (stage III or IV, platinum insensitive disease, i.e. progression within 6 months of initial platinum chemotherapy) * Thymoma (unresectable disease) Exclusion Criteria: 1. Prior allogeneic stem cell or bone marrow transplant 2. Current or past history of invasive mycotic infection 3. Breast Feeding
References
Publications (0)
Data not yet available
No reference posted for this study.