Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02960646|
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : July 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome Acute Myeloid Leukemia in Remission Adult Acute Lymphoblastic Leukemia in Complete Remission Aplastic Anemia Blasts Under 10 Percent of Bone Marrow Nucleated Cells Chronic Myelogenous Leukemia, BCR-ABL1 Positive Chronic Myelomonocytic Leukemia Hematopoietic Cell Transplantation Recipient Minimal Residual Disease Myeloproliferative Neoplasm Plasma Cell Myeloma Recurrent Chronic Lymphocytic Leukemia Recurrent Hodgkin Lymphoma Recurrent Non-Hodgkin Lymphoma Recurrent Plasma Cell Myeloma Recurrent Small Lymphocytic Lymphoma Therapy-Related Myelodysplastic Syndrome||Drug: Cyclophosphamide Biological: Filgrastim Drug: Fludarabine Phosphate Other: Laboratory Biomarker Analysis Drug: Melphalan Procedure: Peripheral Blood Stem Cell Transplantation Biological: Rituximab Drug: Tacrolimus Radiation: Total-Body Irradiation||Phase 1|
I. To assess the safety of a modified peripheral blood (PB) graft for haploidentical transplantation, obtained by using depletion of naive, cluster of differentiation (CD)45RA+ T cells.
I. To estimate the proportion of patients with engraftment/graft failure. II. To determine the day 100 and 6 month non-relapse mortality (NRM). III. To estimate the cumulative incidence of grade 2-4 and 3-4 acute graft versus (vs.) host disease (aGVHD).
IV. To assess the rate of chronic GVHD within the first year post transplantation.
V. To assess immune reconstitution and the incidence of infectious episodes. VI. To assess disease response, disease-free survival (DFS) and overall survival (OS) after transplantation.
VII. To compare results with a retrospective cohort of patients treated with bone marrow graft on protocol 2009-0266.
Patients receive melphalan intravenously (IV) over 30 minutes on day -6 and fludarabine phosphate IV over 1 hour on days -6 to -3. Patients undergo total-body irradiation (TBI) on day -2 and CD45RA depleted peripheral blood stem cell transplantation on day 0. Patients also receive cyclophosphamide IV over 3 hours on days 3-4. Beginning on day 5, patients receive tacrolimus IV for 2 weeks and orally (PO) for at least 4 months. Beginning on day 7, patients receive filgrastim subcutaneously (SC) daily. Patients with CD20 positive lymphoma may receive rituximab IV on days -13, -6, 1, and 8.
After completion of study treatment, patients are followed up periodically.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Clinical Trial Using an Engineered Peripheral Blood Graft for Haploidentical Transplantation|
|Actual Study Start Date :||January 18, 2017|
|Estimated Primary Completion Date :||February 28, 2020|
|Estimated Study Completion Date :||February 28, 2020|
Experimental: Treatment (peripheral blood stem cell transplantation)
Patients receive melphalan IV over 30 minutes on day -6 and fludarabine phosphate IV over 1 hour on days -6 to -3. Patients undergo total-body irradiation (TBI) on day -2 and CD45RA depleted peripheral blood stem cell transplantation on day 0. Patients also receive cyclophosphamide IV over 3 hours on days 3-4. Beginning on day 5, patients receive tacrolimus IV for 2 weeks and PO for at least 4 months. Beginning on day 7, patients receive filgrastim SC daily. Patients with CD20 positive lymphoma may receive rituximab IV on days -13, -6, 1, and 8.
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Procedure: Peripheral Blood Stem Cell Transplantation
Undergo CD45RA depleted peripheral blood stem cell transplantation
Given IV or PO
Radiation: Total-Body Irradiation
- Incidence of treatment failure defined as primary graft failure, grade 3-4 acute graft versus host disease (aGVHD), or non-relapse mortality [ Time Frame: Up to 100 days ]
- Immune reconstitution [ Time Frame: Up to 3 years ]Will be summarized by number of participants.
- Incidence of infectious episodes [ Time Frame: Up to 3 years ]Will be summarized by number of participants.
- Disease free survival (DFS) time [ Time Frame: Up to 3 years ]Will be estimated using the method of Kaplan and Meier.
- Overall survival (OS) time [ Time Frame: Up to 3 years ]Will be estimated using the method of Kaplan and Meier.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960646
|Contact: Stefan Ciureaemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Stefan O. Ciurea 713-792-8750|
|Principal Investigator: Stefan O. Ciurea|
|Principal Investigator:||Stefan O Ciurea||M.D. Anderson Cancer Center|