Clinical trial · Interventional
T-cell Depleted Bone Marrow and G-CSF Stimulated Peripheral Stem Cell Transplantation From Related Donors in Treating Patients With Leukemia, Lymphoblastic Lymphoma, Myelodysplastic Syndrome, or Aplastic Anemia
A Phase II Trial of T-Cell Depleted Marrow Grafts Combined With Infusions of G-CSF Stimulated, CD34 Ceprate Stem Cell Column Selected, E-Rosette Depleted Peripheral Blood Progenitor Cells Derived From HLA Haplotype Matched Related Donors for Patients With Leukemia Lacking an HLA-Matched Related or Unrelated Donor
- 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 and peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of T-cell depleted bone marrow and G-CSF stimulated peripheral stem cell transplantation in treating patients with leukemia, lymphoblastic lymphoma, myelodysplastic syndrome, or aplastic anemia.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic/Myeloproliferative Neoplasms | Myelodysplastic/Myeloproliferative Neoplasm | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| in vitro-treated bone marrow transplantation | Procedure | — | UNRESOLVED |
| in vitro-treated peripheral blood stem cell transplantation | Procedure | — | UNRESOLVED |
| methylprednisolone | Drug | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Candidates for transplant
- description
- Pts stratified by number of HLA-incompatible alleles(1 vs 2 or 3). Harvest:Begin 6-10 d before transplant,allogeneic BM is harvest \& tx in vitro. Begin 5-6 d before transplant,G-CSF-stimulated,PBSC harvest,selected for CD34+ cells,\& treatment in vitro. If doable,ABM harvest in event of allogeneic graft failure. Myeloablation:Pts u/g TBI 3x d days -9 to -6, thiotepa IV over 4hrs days -5 \& -4, \& cyclophosphamide IV days -3 \& -2. Transplant:CD34+, E-rosette \& T-cell-depleted PBSC infuse over 15mins \& T-cell-depleted bone marrow infused over 1-5mins day 0. Pts get G-CSF IV over 30 min begin day 1 \& continue til blood counts recover \& tapering. Pts get anti-thymocyte globulin IV over 4-6hrs days 8,10,12,\&14 \& oral methylprednisolone days 8-14 followed by tapered doses days 15-17. See detailed description for more details.
- interventionNames
- Biological: anti-thymocyte globulin
- Biological: filgrastim
- Drug: cyclophosphamide
- Drug: cytarabine
- Drug: methylprednisolone
- Drug: thiotepa
- Procedure: in vitro-treated bone marrow transplantation
- Procedure: in vitro-treated peripheral blood stem cell transplantation
- Radiation: radiation therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 49 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* One of the following diagnoses:
* Acute myelogenous leukemia (AML) meeting 1 of the following conditions:
* Failed to achieve first remission after an intensive induction regimen containing an anthracycline and cytarabine
* In second remission and not enrolled in a protocol for autologous bone marrow transplantation
* Failed to achieve or sustain second remission
* In first remission but at high risk of relapse because of 1 of the following factors:
* High-risk cytogenetic features (monosomy 7,5q-, trisomy 8, or t(9;22))
* AML secondary to treatment of a prior malignancy and without good-risk cytogenetic features of t(8;21), t(15;17), or inv 16
* AML secondary to myelodysplastic disease
* Acute lymphocytic leukemia (ALL) meeting 1 of the following conditions:
* In second remission with initial relapse occurring within 2 years of diagnosis
* In first complete remission with high-risk cytogenetics (t(9;22) or t(4;11))
* In third or subsequent remission
* Failed to achieve or sustain a second remission
* Chronic myelogenous leukemia (CML) in first or second chronic phase or accelerated phase
* Stage IV lymphoblastic lymphoma not in first remission or that failed to achieve a remission within the first 4 weeks of induction therapy
* Juvenile CML
* Myelodysplastic syndrome
* Severe aplastic anemia unresponsive to anti-thymocyte globulin or cyclosporine
* No CNS or skin involvement with leukemia
* No requirement for mediastinal irradiation
* No healthy, HLA-identical related donor of at least 1 year of age or matched unrelated donor available within 4-6 months
* Availability of a healthy, 1-3 HLA-A, -B, and -DR mismatched related donor
* Willing and able to undergo general anesthesia for marrow donation and a 5-day course of filgrastim (G-CSF) with 2 daily leukaphereses
PATIENT CHARACTERISTICS:
Age:
* Under 50 (50 and over allowed on a case-by-case basis)
Performance status:
* Age 16 and over:
* Karnofsky 70-100%
* Under age 16:
* Lansky 50-100%
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin less than 2.0 mg/dL (in the absence of liver involvement)
* AST less than twice normal (in the absence of liver involvement)
Renal:
* Creatinine normal OR
* Creatinine clearance greater than 60 mL/min
Cardiovascular:
* Asymptomatic or LVEF greater than 50% at rest, with improvement during exercise
Pulmonary:
* Asymptomatic or DLCO greater than 50% predicted (corrected for hemoglobin)
Other:
* No known hypersensitivity to mouse protein or chicken egg products
* No active viral, bacterial, or fungal infection
* HIV-1, HIV-2, HTLV-1, and HTLV-2 negative
* No other concurrent medical condition that would preclude transplantation
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
Surgery
* See Disease CharacteristicsReferences
Publications (0)
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