2-Step Approach to Stem Cell Transplant in Treating Participants With Hematological 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: NCT03712878|
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : February 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hematopoietic and Lymphoid Cell Neoplasm||Radiation: Total-Body Irradiation Procedure: Donor Lymphocyte Infusion Drug: Cyclophosphamide Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Drug: Tacrolimus Drug: Mycophenolate Mofetil||Phase 2|
I. To assess whether providing a patient with "5+5" dosing in a 2 step matched related donor hematopoietic stem cell transplantation (HSCT) increases the percentage of patients who achieve full donor chimerism earlier as defined by 98% or greater donor T cell chimerism at 28 days post HSCT (d+28).
I. To assess day (d) +90 chimerism in patients receiving "5+5" dosing. II. To assess post HSCT relapse rates in patients receiving "5+5" dosing. III. To assess rates of grade II-IV graft versus host disease (GVHD) in patients receiving "5+5" dosing.
IV. To assess treatment-related mortality (TRM) in patients receiving "5+5" dosing.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A 2 Step Approach to Matched Related Hematopoietic Stem Cell Transplantation for Patients With Hematological Malignancies-5+5 Dosing|
|Actual Study Start Date :||September 19, 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Experimental: Treatment (TBI, DLI, chemotherapy, HSCT, tacrolimus, MMF)
Description CONDITIONING REGIMEN: Participants undergo TBI BID on days -9 to -6.
TRANSPLANT: Participants receive donor lymphocytes IV on day -6 after the last dose of TBI.
CONDITIONING REGIMEN: Participants receive cyclophosphamide IV on days -3 and -2.
TRANSPLANT: Participants undergo hematopoietic stem cell transplantation on day 0.
GVHD PROPHYLAXIS: Participants receive tacrolimus IV beginning on day -1 with taper beginning on day 42 in the absence of GVHD, a suspicion of GVHD, or previous history of GVHD requiring a taper delay. Participants also receive mycophenolate mofetil IV BID beginning on day -1 through day 28 in the absence of GVHD.
Radiation: Total-Body Irradiation
Procedure: Donor Lymphocyte Infusion
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Other Name: Allogeneic Hematopoietic Cell Transplantation
Drug: Mycophenolate Mofetil
Other Name: CellCept
- Donor T cell chimerism [ Time Frame: At day +28 ]For chimerism rates, the method of Atkinson and Brown will be used to allow for the two-stage design. Will be presented with corresponding 95% confidence intervals.
- Donor T cell chimerism [ Time Frame: At day +90 ]Will be presented with corresponding 95% confidence intervals. For chimerism rates, the method of Atkinson and Brown will be used to allow for the two-stage design.
- Relapse rate [ Time Frame: At 1 year post-hematopoietic stem cell transplantation (HSCT) ]Will be presented with corresponding 95% confidence intervals.
- Incidence of grades II-IV graft versus host disease (GVHD) [ Time Frame: Within 1 year of HSCT ]Will be presented with corresponding 95% confidence intervals.
- Rate of treatment-related mortality (TRM) [ Time Frame: At 1 year post-HSCT ]Will be presented with corresponding 95% confidence intervals.
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): NCT03712878
|Contact: Dolores Grosso, CRNP||(215) email@example.com|
|United States, Pennsylvania|
|Sidney Kimmel Cancer Center at Thomas Jefferson University||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Contact: Dolores Grosso, CRNP 215-955-8874 firstname.lastname@example.org|
|Principal Investigator:||Neal Flomenberg, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|