A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies-Increasing GVT Effects Without Increasing Toxicity
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|ClinicalTrials.gov Identifier: NCT03032783|
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : December 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hematopoietic and Lymphoid Cell Neoplasm||Radiation: Total-Body Irradiation Procedure: Donor Lymphocyte Infusion Drug: Cyclophosphamide Drug: Tacrolimus Drug: Mycophenolate Mofetil Procedure: Allogeneic Hematopoietic Stem Cell Transplantation||Phase 2|
1. To assess 2 year probability of OS in high risk patients undergoing a myeloablative 2 step HSCT utilizing strategies to decrease relapse.
- To assess relapse incidence at 2 years post-HSCT of patients undergoing treatment on this protocol.
- To assess regimen related toxicity and GVHD incidence at 2 years post-HSCT and severity in patients undergoing treatment on this protocol.
- To assess the consistency and pace of engraftment.
- To assess the pace of T cell and B cell immune recovery.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies-Increasing GVT Effects Without Increasing Toxicity|
|Actual Study Start Date :||January 31, 2017|
|Estimated Primary Completion Date :||July 24, 2021|
|Estimated Study Completion Date :||July 24, 2021|
Experimental: Treatment (TBI, DLI, chemotherapy, HSCT)
Patients undergo Total-Body Irradiation (TBI) twice daily on days -10 to -8 and and donor lymphocyte infusion (DLI) on day -6. Patients receive cyclophosphamide IV on days -3 and -2, tacrolimus IV beginning on day -1 and then orally at least 2 or 3 days prior to discharge with taper starting on day 42, and mycophenolate mofetil IV twice daily on days -1 to 28. Patients undergo Allogeneic Hematopoietic Stem Cell Transplantation on day 0.
Radiation: Total-Body Irradiation
Undergo Total Body Irradiation
Other Name: Total Body Irradiation
Procedure: Donor Lymphocyte Infusion
Undergo Donor Lymphocyte Infusion
Drug: Mycophenolate Mofetil
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Undergo Hematopoietic Stem Cell Transplantation
- Overall Survival (OS) [ Time Frame: At two years ]Will be tested using an exact one-sided binomial test with alpha 0.05. The trial will be considered successful if the null hypothesis of 45% 2-year OS is rejected. In addition, the exact binomial 95% confidence interval for 2-year OS will be computed.
- Incidence of graft failure [ Time Frame: Up to 2 years ]Should be less than 10%
- Incidence of non-relapse mortality [ Time Frame: Up to 2 years ]Should be less than 20% at 100 days
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): NCT03032783
|Contact: Dolores Grosso, DNPfirstname.lastname@example.org|
|Contact: Neal Flomenberg, MDemail@example.com|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Dolores Grosso, DNP 215-955-8874|
|Principal Investigator:||Dolores Grosso, DNP||Sidney Kimmel Cancer Center at Thomas Jefferson University|