Clinical trial · Interventional
Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression
Haploidentical Allogeneic Peripheral Blood Transplantation: Clinical Trial and Laboratory Correlates Examining Checkpoint Immune Regulators' Expression
NCT03480360CI-TRIAL-00118421completedPhase 3Results 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 standard Johns Hopkins' regimen will be used in study subjects, with the use of donor peripheral blood stem cells, rather than marrow. Clinical outcomes will be defined while focusing efforts on immune reconstitution focusing on immune checkpoint regulators after a related haploidentical stem cell transplant.
Conditions
Conditions (9)
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 Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplasia | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myelofibrosis | Primary Myelofibrosis | ALIAS | 0.90 |
| Myeloproliferative Disorder | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Plasma Cell Disorder | — | UNRESOLVED |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cellcept | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| g-csf | Drug | — | UNRESOLVED |
| Peripheral Blood Transplant | Procedure | — | UNRESOLVED |
| Tacrolimus | Drug | — | UNRESOLVED |
| Total Body Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Johns Hopkins' conditioning regimen
- description
- Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant
- interventionNames
- Drug: Cyclophosphamide
- Drug: Fludarabine
- Radiation: Total Body Irradiation
- Drug: Tacrolimus
- Drug: cellcept
- Drug: g-csf
- Procedure: Peripheral Blood Transplant
Primary outcomes (10)
- measure
- Number of Participants Who Survived to 100-Days Post-transplant
- timeFrame
- 100 days post date of peripheral blood transplant
- description
- Define 100-day survival of subjects
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age: less than 75 years * The patient must be approved for transplant by the treating transplant physician. This includes completion of their pre-transplant workup, as directed by standard Dartmouth-Hitchcock Medical Center (DHMC) Standard Operating Procedure (SOP) (DHMC SOP - Pre-transplant Evaluation of allogeneic recipient (Appendix). * The patient must have a disease (listed below) with treatment-responsiveness that the treating transplant physician believes will benefit from an allogeneic stem cell transplant. The diseases include: * Acute leukemia - Acute Myeloid Leukemia, Acute Lymphocytic Leukemia * Chronic leukemia - Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia * Myelodysplasia * Myeloproliferative disorder * Myelofibrosis * Lymphoma - Non-Hodgkin's Lymphoma or Hodgkin's disease * Plasma cell disorder, including myeloma, Waldenstrom's Macroglobulinemia * Donor availability- the patient must have an identified RELATED haplo-identical donor * No Human Immunodeficiency Virus infection or active hepatitis B or C * Eastern Cooperative Oncology Group performance status: 0-2 * Diffusing capacity of carbon monoxide (DLCO) greater than or equal to 40 % predicted * Left ventricular ejection fraction greater than or equal to 40% * Serum bilirubin \< 2x upper limit of normal; transaminases \< 3x normal at the time of transplant * No active or uncontrollable infection * In female, a negative pregnancy test if experiencing menstrual periods * No major organ dysfunction precluding transplantation * No evidence of an active malignancy that would limit the patient's survival to less than 2 years. (If there is any question, the PI can make a decision). Exclusion Criteria: * Psychiatric disorder or a mental deficiency of the patient that is sufficiently severe to make compliance with the treatment unlikely, and making informed consent impossible. * Major anticipated illness or organ failure incompatible with survival from bone marrow transplant. * History of refractory systemic infection DONOR ELIGIBILITY * Human leukocyte antigen (HLA) haplo-identical matched related. * The donor must be healthy and must be willing to serve as a donor, based on standard National Marrow Donor Program (NMDP) guidelines and DHMC SOP - Donor Evaluation (Appendix) * The donor must have no significant co-morbidities that would put the donor at marked increased risk * There is no age restriction for the donor * Informed consent must be signed by donor DONOR EXCLUSION CRITERIA * The NMDP guidelines for exclusion criteria will be used (Appendix). In addition, the following donors are NOT eligible: * Pregnant or lactating donor * HIV or active Hep B or C in the donor * Donor unfit to receive G-CSF and undergo apheresis * A donor with a psychiatric disorder or mental deficiency that makes compliance with the procedure unlikely and informed consent impossible
References
Publications (23)
- BACKGROUNDBashey A, Zhang X, Sizemore CA, Manion K, Brown S, Holland HK, Morris LE, Solomon SR. T-cell-replete HLA-haploidentical hematopoietic transplantation for hematologic malignancies using post-transplantation cyclophosphamide results in outcomes equivalent to those of contemporaneous HLA-matched related and unrelated donor transplantation. J Clin Oncol. 2013 Apr 1;31(10):1310-6. doi: 10.1200/JCO.2012.44.3523. Epub 2013 Feb 19. PMID 23423745
- BACKGROUNDSolomon SR, Sizemore CA, Sanacore M, Zhang X, Brown S, Holland HK, Morris LE, Bashey A. Haploidentical transplantation using T cell replete peripheral blood stem cells and myeloablative conditioning in patients with high-risk hematologic malignancies who lack conventional donors is well tolerated and produces excellent relapse-free survival: results of a prospective phase II trial. Biol Blood Marrow Transplant. 2012 Dec;18(12):1859-66. doi: 10.1016/j.bbmt.2012.06.019. Epub 2012 Aug 1. PMID 22863841
- BACKGROUNDCiurea SO, Zhang MJ, Bacigalupo AA, Bashey A, Appelbaum FR, Aljitawi OS, Armand P, Antin JH, Chen J, Devine SM, Fowler DH, Luznik L, Nakamura R, O'Donnell PV, Perales MA, Pingali SR, Porter DL, Riches MR, Ringden OT, Rocha V, Vij R, Weisdorf DJ, Champlin RE, Horowitz MM, Fuchs EJ, Eapen M. Haploidentical transplant with posttransplant cyclophosphamide vs matched unrelated donor transplant for acute myeloid leukemia. Blood. 2015 Aug 20;126(8):1033-40. doi: 10.1182/blood-2015-04-639831. Epub 2015 Jun 30. PMID 26130705
- BACKGROUNDLuznik L, O'Donnell PV, Symons HJ, Chen AR, Leffell MS, Zahurak M, Gooley TA, Piantadosi S, Kaup M, Ambinder RF, Huff CA, Matsui W, Bolanos-Meade J, Borrello I, Powell JD, Harrington E, Warnock S, Flowers M, Brodsky RA, Sandmaier BM, Storb RF, Jones RJ, Fuchs EJ. HLA-haploidentical bone marrow transplantation for hematologic malignancies using nonmyeloablative conditioning and high-dose, posttransplantation cyclophosphamide. Biol Blood Marrow Transplant. 2008 Jun;14(6):641-50. doi: 10.1016/j.bbmt.2008.03.005. PMID 18489989
- BACKGROUNDMielcarek M, Martin PJ, Leisenring W, Flowers ME, Maloney DG, Sandmaier BM, Maris MB, Storb R. Graft-versus-host disease after nonmyeloablative versus conventional hematopoietic stem cell transplantation. Blood. 2003 Jul 15;102(2):756-62. doi: 10.1182/blood-2002-08-2628. Epub 2003 Mar 27.