B Cells-TumorsPhase 1NCT03151057
Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies
A Phase 1 study testing Idelalisib 100 MG in people with B Cells-Tumors and B Cell Chronic Lymphocytic Leukemia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This is a study to evaluate the safety of idelalisib as post-transplantation maintenance in patients with B cell hematologic malignancies undergoing a allogeneic hematopoietic stem cell transplant (HSCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B Cells-Tumors, B Cell Chronic Lymphocytic Leukemia, Follicular Lymphoma
- What is being tested?
- Idelalisib 100 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2018to 20 Jul 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years of age
- Has undergone allo HSCT to treat a B-cell derived hematologic malignancy: accepted alloHSCT regimens include: myeloablative or reduced intensity conditioning from any donor (matched, partially mismatched or cord) and any source (peripheral blood, bone marrow, or cord).
- T bili ≤ 1.5 mg/dL except for patients with Gilbert's syndrome or hemolysis
- AST, ALT and alk phos all < 2.5X ULN
- Karnofsky performance score ≥ 40
- ECOG ≤3
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- For women of childbearing potential, a negative serum or urine pregnancy test with sensitivity less than 50 mIU/m within 72 hours before the start of study medication.
- Use of two forms of contraception with less than a 5% failure rate or abstinence by all transplanted patients for a minimum of 1 month after the last dose of Idelalisib. For the first 60 days post-transplant, transplant recipients should be encouraged to use non-hormonal contraceptives due to the potential adverse effect of hormones on bone marrow engraftment.
- Ability to receive oral medication.
- Ability to understand and provide informed consent.
Who cannot join
- ECOG >3 (Karnofsky <40%)
- ALT, AST >2.5 ULN or total bilirubin >1.5 ULN (not attributable to Gilbert's)
- Women who are pregnant or breastfeeding.
- Exclude if patient has cirrhosis or is currently being actively treated for hepatitis C.
- History of positive HIV-1 or HIV-2 serologies or nucleic acid test.
- Active hepatitis B infection as documented by positive Hepatitis B PCR assay
Show all 11Show fewer
- Use of investigational drug, other than the study medications specified by the protocol, within 30 days of transplantation.
- Receipt of a live vaccine within 30 days of receipt of study therapy.
- ≥ Grade II aGVHD
- The presence of any medical condition that the Investigator deems incompatible with participation in the trial
- Subjects who are required to use a medication classified as a strong CYP3A inducer of inhibitor.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21205
About this study
Official title: Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies: A Phase 1 Double Blinded Randomized Placebo Toxicity Trial
This is a study to evaluate the safety of idelalisib as post-transplantation maintenance in patients with B cell hematologic malignancies undergoing a allogeneic hematopoietic stem cell transplant (HSCT). Safety will be evaluated through the assessment of cytopenias, effect on donor chimerism, effect on the incidence and severity of acute graft versus host disease, and gastro-intestinal tolerance.
Read the detailed description
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.
- Conditions
- B Cells-Tumors, B Cell Chronic Lymphocytic Leukemia, Follicular Lymphoma, Mantle Cell Lymphoma, Large B-Cell Diffuse Lymphoma of Bone (Diagnosis)
- Being tested
- Idelalisib 100 MG, Placebo Oral Tablet
- Keywords
- Idelalisib, Zydelig, allo transplant, PI3K inhibitor, post transplant maintenance therapy
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Idelalisib 100 MGDrug
Also called Zydelig
100mg BID beginning on day 90 (+/- 10days) and continuing until day 270 post transplant.
Placebo Oral TabletDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Idelalisib 100mg | Experimental | 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 Receives: Drug: Idelalisib 100 MG |
| Placebo oral tablet | Placebo comparator | Placebo to be taken twice daily beginning +90(+/- 10) days after allo HSCT and continued through Day 270 post transplant Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The evaluation of the safety of Idelalisib as post-transplantation maintenance in patients with B cell hematologic malignancies
Measured: Day 90 - Day 270 post transplant
Secondary outcomes (2)
Event Free Survival at One Year.
Impact of Idelalisib on aGVHD, relapse, and non-relapse mortality
Measured: Beginning Day 90 post transplant until Day 360
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
Search for Biomarkers which could better identify which patients would respond to treatment with Idelalisib in the post-transplant setting.
Measured: Beginning Day 90 post transplant until Day 270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start31 Jul 2018
- Primary completion20 Jun 2022
- Study completion20 Jul 2022
Why it stopped: Safety endpointreached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for B Cells-TumorsStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Idelalisib 100mg or placebo twice daily, starting day +90 (+-/ 10 days) after transplant until day +270.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Douglas Gladstone, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151057
- Sponsor's protocol ID
- J1633
- Other IDs
- IRB00157704
- Status last verified
- Aug 2023
- First submitted
- 29 Mar 2017
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies: A Phase 1 Double Blinded Randomized Placebo Toxicity Trial
- ClinicalTrials.gov ID
- NCT03151057
- Acronym / sponsor ID
- J1633
- Conditions
- B Cells-Tumors, B Cell Chronic Lymphocytic Leukemia, Follicular Lymphoma, Mantle Cell Lymphoma, Large B-Cell Diffuse Lymphoma of Bone (Diagnosis)
- Keywords
- Idelalisib, Zydelig, allo transplant, PI3K inhibitor, post transplant maintenance therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety endpointreached
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate the safety of idelalisib as post-transplantation maintenance in patients with B cell hematologic malignancies undergoing a allogeneic hematopoietic stem cell transplant (HSCT). Safety will be evaluated through the assessment of cytopenias, effect on donor chimerism, effect on the incidence and severity of acute graft versus host disease, and gastro-intestinal tolerance.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Idelalisib 100mg or placebo twice daily, starting day +90 (+-/ 10 days) after transplant until day +270.
| Arm | Type | Receives |
|---|---|---|
| Idelalisib 100mg | Experimental | Drug: Idelalisib 100 MGIdelalisib 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 |
| Placebo oral tablet | Placebo comparator | Drug: Placebo Oral TabletPlacebo to be taken twice daily beginning +90(+/- 10) days after allo HSCT and continued through Day 270 post transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- >18 years of age
- Has undergone allo HSCT to treat a B-cell derived hematologic malignancy: accepted alloHSCT regimens include: myeloablative or reduced intensity conditioning from any donor (matched, partially mismatched or cord) and any source (peripheral blood, bone marrow, or cord).
- T bili ≤ 1.5 mg/dL except for patients with Gilbert's syndrome or hemolysis
- AST, ALT and alk phos all < 2.5X ULN
- Karnofsky performance score ≥ 40
Key exclusion criteria (11 listed)
- ECOG >3 (Karnofsky <40%)
- ALT, AST >2.5 ULN or total bilirubin >1.5 ULN (not attributable to Gilbert's)
- Women who are pregnant or breastfeeding.
- Exclude if patient has cirrhosis or is currently being actively treated for hepatitis C.
- History of positive HIV-1 or HIV-2 serologies or nucleic acid test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Idelalisib 100 MGAlso: Zydelig100mg BID beginning on day 90 (+/- 10days) and continuing until day 270 post transplant. | Drug | Idelalisib 100mg |
| Placebo Oral Tabletplacebo | Drug | Placebo oral tablet |
Primary outcome
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
2 secondary outcomes
Event Free Survival at One Year.
Time frame: Beginning Day 90 post transplant until Day 360
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Gladstone, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Idelalisib 100 MG in people with B Cells-Tumors and B Cell Chronic Lymphocytic Leukemia, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.