Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived 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: NCT03151057|
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : September 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|B Cells-Tumors B Cell Chronic Lymphocytic Leukemia Follicular Lymphoma Mantle Cell Lymphoma Large B-Cell Diffuse Lymphoma of Bone (Diagnosis)||Drug: Idelalisib 100 MG Drug: Placebo Oral Tablet||Phase 1|
Currently, to improve overall survival, the focus of the BMT program at JHH the introduction of anti-neoplastic therapy post transplantation: where the allo BMT serves as a platform to allowing a new intolerant immune system to interact with the post allo BMT intervention.
The importance of post BMT therapy has been made evident with tyrosine kinase inhibition (TKI) in Philadelphia chromosome positive acute lymphocytic leukemia (ALL) and chronic myeloid leukemia(CML), where patients who had disease progression while on TKI therapy pre-allo BMT enjoy marked improvement in overall survival when TKI is part of a maintenance program; the use of DNA hypomethylation agents after allo BMT for relapsed myeloid malignances; or the use of rituximab after allo BMT in follicular lymphoma.
Idelalisib, an orally-administered, selective inhibitor of Phosphoinositide 3 kinase (PI3K), is extremely effective in inducing partial responses to complete responses in many B-cell derived malignancies and should be studied in the post alloHSCT setting. Johns Hopkins Hospital has one of the world's largest experiences with alloHSCT. This study proposes a double blinded randomized phase I placebo trial where all patients who have undergone alloHSCT for a B-cell derived hematologic malignancy be offered either idelalisib 100mg or placebo twice daily for 180 days starting approximately 90 days after their HSCT.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Idelalisib 100mg or placebo twice daily, starting day +90 (+-/ 10 days) after transplant until day +270.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Participant, investigator|
|Official Title:||Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies: A Phase 1 Double Blinded Randomized Placebo Toxicity Trial|
|Actual Study Start Date :||July 31, 2018|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Idelalisib 100mg
Idelalisib is an orally-administered, selective inhibitor of Phosphoinositide 3 kinase (PI3K)-delta which has been shown to be extremely effective in inducing partial to complete responses in many B-cell derived malignancies.
intervention: 100mg Idelalisib twice daily beginning +90(+/- 10) days after allo HSCT and continued through Day 270 post transplant
Drug: Idelalisib 100 MG
100mg BID beginning on day 90 (+/- 10days) and continuing until day 270 post transplant.
Other Name: Zydelig
Placebo Comparator: Placebo oral tablet
Placebo to be taken twice daily beginning +90(+/- 10) days after allo HSCT and continued through Day 270 post transplant
Drug: Placebo Oral Tablet
- Treatment-limiting toxicities will be defined as Idelalisib interruption for >14 days, or other >3 adverse events as defined by CTCAE IV not captured in the protocol for dose de-escalation. [ Time Frame: Day 90 - Day 270 post transplant ]The evaluation of the safety of Idelalisib as post-transplantation maintenance in patients with B cell hematologic malignancies
- Event free survival at one year. [ Time Frame: Beginning Day 90 post transplant until Day 360 ]Impact of Idelalisib on aGVHD, relapse, and non-relapse mortality
- Identify potential predictive biomarker candidates based on exploratory gene expression analysis of immune biomarkers in bone marrow aspirates and whole or targeted exome sequencing of lymphoma cells [ Time Frame: Beginning Day 90 post transplant until Day 270 ]Search for Biomarkers which could better identify which patients would respond to treatment with Idelalisib in the post-transplant setting.
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): NCT03151057
|Contact: Laura Ackley, RNemail@example.com|
|Contact: Mary Amanda Stevens, MDfirstname.lastname@example.org|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Contact: Douglas Gladstone, MD 410-955-8781 email@example.com|
|Contact: Mary A Stevens, MD 443-287-0180 firstname.lastname@example.org|
|Principal Investigator:||Douglas Gladstone, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|