Clinical trial · Interventional
Study of Infusion of Blood Cells (Lymphocytes) to Stimulate the Immune System to Fight Leukemia/Lymphoma
BrUOG 273:Cellular Immunotherapy For Refractory Hematological Malignancies:A Brown University Oncology Research Group Study
NCT01685606CI-TRIAL-00056887273terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of accrual and low efficacy
Summary
Brief summary (as posted)
The study of whether an infusion of blood cells called lymphocytes from a donor can stimulate the immune system to fight your leukemia/lymphoma.
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 |
|---|---|---|---|
| Acute Myeloid Leukemia/Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
| Burkitts Lymphoma | Burkitt Lymphoma | ALIAS | 0.90 |
| Diffuse Large Cell Lymphoma | — | UNRESOLVED | — |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| T Cell Lymphomas | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cellular immunotherapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cellular immunotherapy
- description
- A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.
- interventionNames
- Biological: cellular immunotherapy
Primary outcomes (1)
- measure
- Overall Response Rate of Cellular Immune Therapy With HLA Haploidentical Peripheral Blood Pheresed Cells in Patients With Relapsed/Refractory Hematological Malignancies.
- timeFrame
- 8 weeks after infusion then 6 months after and every 4 months for approximately 2 years
- description
- Criteria for AML and ALL (adapted from Cheson et al.20) Complete remission (CR) is defined as the presence of all of the following * Peripheral blood o No leukemic blasts present. * No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement) * Bone marrow * Cellularity \>20% with baseline maturation. * No Auer rods * Less than 5% blast cells. * Complete blood counts and bone marrow normalization criteria must be met within one week of each other. Hematopoeitic recovery is an ANC \> 1.0 x 109/L and platelet count \> 100x109/L. No specific hemoglobin or hematocrit level is specified but the patient must be transfusion free. Complete remission with incomplete recovery (CRi) is defined as the following: * Meets criteria for CR except * ANC \< 1.0 x 109/L or platelet count \< 100x109/L Partial remission (PR). • Must meet all criteria of a CR except that the bone marrow may contain 5-20% blasts.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic confirmation of hematological malignancy consisting of the following leukemias/lymphomas: * Mantle cell lymphoma with Ki-67\>30% * Diffuse Large Cell Lymphoma * Burkitts Lymphoma * Systemic T Cell Lymphomas * Acute Myeloid Leukemia * Acute Lymphoblastic Leukemia * Recurrence or progression of hematological malignancy after at least 1 prior standard treatment with progression within 6 months from last treatment. * No curative treatment option is available. -\> 4-weeks since prior chemotherapy or radiation to cellular therapy infusion. (Hydroxyurea may be utilized up to 48 hours prior to initiation of treatment on this protocol). * Age equal to or greater than 18 years. * Patients with a history of invasive second malignancy unless disease free for \> 5 years. * Patients must have an expected life expectancy of at least 2 months at the time of initiation of treatment. * No active systemic infection. * Patients who have relapsed after standard autologous stem cell infusion are eligible as long as they meet all inclusion criteria and no exclusion criteria. These patients must be out more than 6 months from cell infusion to be eligible for enrollment. * DLCO \> 40% with no symptomatic pulmonary disease. * LVEF \> 40% by MUGA or echocardiogram. * Creatinine \< 2.0 mg/dl. Total bilirubin less than 1.5x the upper limit of normal (ULN), AST \< 3x ULN. * Non-pregnant and willing to use appropriate birth control during the duration of the study period. Exclusion Criteria: * Evidence of HIV infection. * Any uncontrolled severe, concurrent illness which in the opinion of the treating physician would make this protocol treatment unreasonably hazardous for the patient. * Oxygen dependent obstructive pulmonary disease. * Failure to demonstrate adequate compliance with medical therapy and follow-up. * Significant medical or psychiatric illness that would impair the ability to participate in protocol therapy. * For women of reproductive potential, refusal to use effective form of contraception. * Previous allogeneic stem cell transplant * Patients who have had previous purine analog (fludarabine, pentostatin, 2-CDA) -Patients with chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), multiple myeloma, and indolent lymphoma (follicular lymphoma, marginal zone lymphoma) * Patients with HLA antibodies to donor HLA type.
References
Publications (1)
- DERIVEDReagan JL, Fast LD, Safran H, Nevola M, Winer ES, Castillo JJ, Butera JN, Quesenberry MI, Young CT, Quesenberry PJ. Cellular immunotherapy for refractory hematological malignancies. J Transl Med. 2013 Jun 19;11:150. doi: 10.1186/1479-5876-11-150. PMID 23782682