Relapsed Hematologic MalignancyPhase 1/2ARIANCT05205252
A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.
A Phase 1/2 study testing Tazemetostat, Tafasitamab and Lenalidomide in people with Relapsed Hematologic Malignancy and Refractory Hematologic Malignancy, run by Epizyme, Inc. at 3 sites in United States.
Trial summary
This trial will study how safely the tazemetostat works with other therapies in various hematological malignancies. Hematologic malignancies are cancers that most often begin in the bone marrow or lymph nodes where blood precursors are produced. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Hematologic Malignancy, Refractory Hematologic Malignancy
- What is being tested?
- Tazemetostat, Tafasitamab and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Dec 2021to 5 Jul 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 for Phase 1b and status 0 to 2 for Phase 2
- Must have documented relapsed, refractory, or progressive disease after 2 lines of treatment with systemic therapy
- Measurable disease
- Demonstrate adequate organ function
- Negative test results for acute or chronic hepatitis B virus (HBV) infection, hepatitis C virus (HCV) and human immunodeficiency virus
- No ongoing clinically significant reactions to prior anticancer treatments
- Willingness to follow pregnancy precautions and register into the mandatory REMS program in lenalidomide and pomalizdomide arms
Who cannot join
- Presence or history of central nervous system involvement by lymphoma
- Less than minimum washout period of prior anticancer therapy as specified by the protocol
- Prior allogeneic haematopoietic stem cell transplantation
- History of solid organ transplant
- Major surgery within 4 weeks of the start of study drug.
- Significant cardiac or cardiovascular impairment as specified by protocol
Show all 26Show fewer
- Venous thrombosis or pulmonary embolism within the last 3 months before starting tazemetostat
- History of any bleeding disorder, peptic ulcer disease, or significant bleeding within the last 1 month prior to enrollment
- Are unable to take oral medication OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition
- Patients with known active infection, or reactivation of a latent infection, as specified by the protocol
- Known sensitivity or allergy to the study medications
- Unwilling to refrain from eating or drinking grapefruit juice, Seville oranges, and grapefruits while on study
- Prior exposure to tazemetostat
- Any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.
- Prior history of myeloid malignancies or T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (T-ALL)
- For patients with DLBCL in Arm 1 (tazemetostat plus tafasitamab plus lenalidomide) or Arm 2 (tazemetostat plus lenalidomide):
- Prior exposure to lenalidomide
- For patients with MCL in Arm 3 (tazemetostat plus acalabrutinib):
- Prior exposure to a BTKi
- Medical condition that would make treatment with a BTKi not reasonable (e.g. allergy to BTKi or mutations known not to respond to BTKi treatment or subjects unable to be transitioned off of proton pump inhibitors)
- For patients with MM in Arm 4:
- Prior exposure to pomalidomide
- Untreated or impending spinal cord compression in subjects
- For patients with FL in Arm 5:
- Grade 3b, mixed histology, or FL that has histologically transformed to DLBCL.
- History of significant neurological disorders, hemophagocytic lymphohistiocytosis (HLH), chronic active Epstein-Barr virus (EBV) infection, progressive multifocal leukoencephalopathy (PML), lung disease (ILD), drug-induced pneumonitis, autoimmune pneumonitis, and/or history of severe autoimmune disease
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Central Care Cancer Center
Bolivar, Missouri, 65613
Astera Cancer Center
East Brunswick, New Jersey, 08816
California Cancer Associates For Research And Excellence, cCARE
Santa Fe, California, 92024
About this study
Official title: ARIA: A Phase 1b/2, Open-label, Multi Cohort Trial of Tazemetostat in Combination With Various Treatments in Subjects With Relapsed or Refractory Hematologic Malignancies
This trial will study how safely the tazemetostat works with other therapies in various hematological malignancies. Hematologic malignancies are cancers that most often begin in the bone marrow or lymph nodes where blood precursors are produced.
They are often called blood cancers and fall into three categories: leukemia, lymphoma and myeloma.
Read more
Tazemetostat has been found to be a safe and effective drug that works in patients with follicular lymphoma where the disease has come back after treatment (known as relapsed) and when other treatment no longer works (known as refractory).
Combining tazemetostat with other treatments may work better in treating patients with hematological malignancies and may improve disease response and durability of response.
Read the detailed description
This phase 1b/2 trial studies how safely the EZH2 inhibitor tazemetostat works with other therapies in various hematological malignancies. Tazemetostat has been found to be a safe and effective drug that works in patients with relapsed refractory (R/R) follicular lymphoma. Giving tazemetostat in combination with other treatments may work better in treating patients with hematological malignancies and may improve disease response and durability of response.
- Being tested
- Tazemetostat, Tafasitamab, Lenalidomide, Acalabrutinib, Daratumumab (Intravenously)
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TazemetostatDrug
Also called IPN60200
Orally, twice daily in continuous 28-day cycles.
TafasitamabDrug
Intravenously, 12 mg/kg, once daily on Cycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle. Cycles 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle. Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle.
LenalidomideDrug
Orally, 10 mg or 20 mg based on kidney function, once daily from Days 1 to 21 of continuous 28-day cycles for up to 12 cycles.
AcalabrutinibDrug
Also called Bruton tyrosine kinase inhibitor
Orally, 100 mg, twice daily.
Daratumumab (Intravenously)Drug
Intravenously, 16 mg/kg actual body weight, once daily on Cycles 1 and 2: Days 1, 8, 15 and 22 of the 28-day cycle. Cycles 3 through 6: Days 1 and 15 each 28-day cycle. Cycle 7 and beyond: Day 1 of each 28-day cycle.
MosunetuzumabDrug
Subcutaneously, step-up doses on Cycle 1 Days 1 (5 mg), 8 (45 mg) and 15 (45 mg) and then 45 mg from Cycle 2 through 12 on Day 1 of the 28-day cycle.
Daratumumab (Subcutaneously)Drug
Subcutaneously, 1800 mg, once daily on Cycles 1 and 2: Days 1, 8, 15 and 22 of the 28-day cycle. Cycles 3 through 6: Days 1 and 15 each 28-day cycle. Cycle 7 and beyond: Day 1 of each 28-day cycle.
Hyaluronidase-FihjDrug
Subcutaneously, 30,000 units, once daily on Cycles 1 and 2: Days 1, 8, 15 and 22 of the 28-day cycle. Cycles 3 through 6: Days 1 and 15 each 28-day cycle. Cycle 7 and beyond: Day 1 of each 28-day cycle.
PomalidomideDrug
Orally, 4 mg, once daily on Days 1 to 21 of continuous 28-day cycles.
Dexamethasone 20mgDrug
Orally, 20 mg or 40 mg, once daily on Days 1, 8, 15, and 22 of continuous 28-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1-Tazemetostat plus tafasitamab-cxix (CD19 Ab)/lenalidomide | Active comparator | Participants with R/R, diffuse large B-cell lymphoma (DLBCL) will receive tazemetostat, tafasitamab, and lenalidomide for approximately 1 year.
After approximately 1 year, participants will receive tazemetostat and tafasitamab. Receives: Drug: Tazemetostat; Drug: Tafasitamab; Drug: Lenalidomide |
| Arm 2-Tazemetostat plus lenalidomide | Active comparator | Participants with R/R DLBCL will receive tazemetostat and lenalidomide for approximately 1 year. After approximately 1 year, participants will receive tazemetostat alone. Receives: Drug: Tazemetostat; Drug: Lenalidomide |
| Arm 3- Tazemetostat plus BTKi (acalabrutinib) | Active comparator | Participants with R/R mantle cell lymphomawill (MCL) will receive tazemetostat and acalabrutinib for the entire study. Receives: Drug: Tazemetostat; Drug: Acalabrutinib; Drug: Hyaluronidase-Fihj |
| Arm 4-Tazemetostat plus CD38 mAbPD (daratumumab/pomalidomide/dexamethasone) | Active comparator | Participants with R/R multiple myelomawill (MM) will receive tazemetostat, daratumumab, pomalidomide, and dexamethasone for the entire study.
Daratumumab may be given intravenously or subcutaneously during this study. Receives: Drug: Tazemetostat; Drug: Daratumumab (Intravenously); Drug: Daratumumab (Subcutaneously); Drug: Pomalidomide; Drug: Dexamethasone 20mg |
| Arm 5- Tazemetostat plus CD20/CD3 BsAb (mosunetuzumab) | Active comparator | Participants with R/R follicular lymphoma will receive tazemetostat and mosunetuzumab for approximately 1 year. After approximately 1 year, participants will receive tazemetostat alone. Receives: Drug: Tazemetostat; Drug: Mosunetuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Recommended Phase 2 Dose (RP2D) of tazemetostat in combination with each partner drug
The safety and tolerability of tazemetostat in combination with each partner drug in participants with R/R malignancies will be evaluated. RP2D of tazemetostat for further evaluation in phase 2 will be selected as assessed by the occurrence of treatment-emergent dose-limiting toxicities (DLTs) and adverse events (AEs).
Measured: Evaluated for DLTs during the first 28-day cycle. The RP2D for Phase 2 for each arm will be selected at the end of that arm's experience in Phase 1b
Phase 2: Objective Response Rate (ORR)
Overall response rate is defined as proportion of participants with a best response of at least partial remission (including partial remission and complete remission for participants with non-Hodgkin lymphoma in Arms 1, 2, 3, or 5 or partial remission, complete remission, stringent complete response, or very good partial response).
Measured: Time from the date of first dose of study drug to the time of response, assessed up to 24 months.
Secondary outcomes (8)
Phase 2: Progression Free Survival (PFS)
Progression free survival is defined as the time from randomization into the study to the first observation of documented disease progression or death due to any cause.
Measured: Up to 24 months.
Time to response (TTR)
Defined as the time from the first dose of study drug to the earliest date of CR or PR per Lugano Classification (Arms 1, 2, 3, and 5) or sCR, CR, VGPR, or PR per IMWG 2016 criteria (Arm 4) as assessed by Investigator review.
Measured: Up to 24 months
Phase 2: Duration of Response (DOR)
Duration of response is defined as the time from the initial response (at least partial remission) to documented disease progression.
Measured: Up to 24 months
Phase 2: Disease control rate (DCR)
Defined as the percentage of participants who achieve complete response (CR), partial response (PR), or stable disease per Lugano Classification (Arms 1, 2, 3, or 5) or stringent complete response (sCR), CR, very good partial response (VGPR), PR, or stable disease per IMWG 2016 criteria (Arm 4) at 6 months on study treatment, as assessed by Investigator review.
Measured: Up to 24 months
Phase 2: Overall Survival (OS)
Overall survival is defined as the time from the first dose of study drug to date of death due to any cause.
Measured: Up to 24 months
Time to next treatment (TTNT)
Defined as the time from the first dose of study drug to the start of subsequent anticancer therapy
Measured: Up to 24 months
Percentage of participants with Treatment Emergent Adverse Event (TEAEs)
An Adverse Event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to 24 months
Percentage of participants with clinically significant changes in laboratory parameters
Percentage of participants with clinically significant changes in laboratory parameters including, hematology, serum chemistry, coagulation and urinalysis will be reported. The clinical significance will be evaluated by the investigator.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start22 Dec 2021
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Why it stopped: Epizyme Inc. has revised the Tazemetostat development strategy and made the decision to terminate the hematological malignancies basket trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Hematologic MalignancyStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epizyme, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205252
- Sponsor's protocol ID
- EZH-1501
- Acronym
- ARIA
- Status last verified
- Aug 2023
- First submitted
- 29 Dec 2021
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARIA: A Phase 1b/2, Open-label, Multi Cohort Trial of Tazemetostat in Combination With Various Treatments in Subjects With Relapsed or Refractory Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT05205252
- Acronym / sponsor ID
- ARIA / EZH-1501
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Epizyme Inc. has revised the Tazemetostat development strategy and made the decision to terminate the hematological malignancies basket trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Epizyme, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will study how safely the tazemetostat works with other therapies in various hematological malignancies. Hematologic malignancies are cancers that most often begin in the bone marrow or lymph nodes where blood precursors are produced.
They are often called blood cancers and fall into three categories: leukemia, lymphoma and myeloma.
Tazemetostat has been found to be a safe and effective drug that works in patients with follicular lymphoma where the disease has come back after treatment (known as relapsed) and when other treatment no longer works (known as refractory).
Combining tazemetostat with other treatments may work better in treating patients with hematological malignancies and may improve disease response and durability of response.
Detailed description
This phase 1b/2 trial studies how safely the EZH2 inhibitor tazemetostat works with other therapies in various hematological malignancies. Tazemetostat has been found to be a safe and effective drug that works in patients with relapsed refractory (R/R) follicular lymphoma. Giving tazemetostat in combination with other treatments may work better in treating patients with hematological malignancies and may improve disease response and durability of response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1-Tazemetostat plus tafasitamab-cxix (CD19 Ab)/lenalidomide | Active comparator | Drug: Tazemetostat, Drug: Tafasitamab, Drug: LenalidomideParticipants with R/R, diffuse large B-cell lymphoma (DLBCL) will receive tazemetostat, tafasitamab, and lenalidomide for approximately 1 year. After approximately 1 year, participants will receive tazemetostat and tafasitamab. |
| Arm 2-Tazemetostat plus lenalidomide | Active comparator | Drug: Tazemetostat, Drug: LenalidomideParticipants with R/R DLBCL will receive tazemetostat and lenalidomide for approximately 1 year. After approximately 1 year, participants will receive tazemetostat alone. |
| Arm 3- Tazemetostat plus BTKi (acalabrutinib) | Active comparator | Drug: Tazemetostat, Drug: Acalabrutinib, Drug: Hyaluronidase-FihjParticipants with R/R mantle cell lymphomawill (MCL) will receive tazemetostat and acalabrutinib for the entire study. |
| Arm 4-Tazemetostat plus CD38 mAbPD (daratumumab/pomalidomide/dexamethasone) | Active comparator | Drug: Tazemetostat, Drug: Daratumumab (Intravenously), Drug: Daratumumab (Subcutaneously), Drug: Pomalidomide, Drug: Dexamethasone 20mgParticipants with R/R multiple myelomawill (MM) will receive tazemetostat, daratumumab, pomalidomide, and dexamethasone for the entire study. Daratumumab may be given intravenously or subcutaneously during this study. |
| Arm 5- Tazemetostat plus CD20/CD3 BsAb (mosunetuzumab) | Active comparator | Drug: Tazemetostat, Drug: MosunetuzumabParticipants with R/R follicular lymphoma will receive tazemetostat and mosunetuzumab for approximately 1 year. After approximately 1 year, participants will receive tazemetostat alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 for Phase 1b and status 0 to 2 for Phase 2
- Must have documented relapsed, refractory, or progressive disease after 2 lines of treatment with systemic therapy
- Measurable disease
- Demonstrate adequate organ function
- Negative test results for acute or chronic hepatitis B virus (HBV) infection, hepatitis C virus (HCV) and human immunodeficiency virus
Key exclusion criteria (26 listed)
- Presence or history of central nervous system involvement by lymphoma
- Less than minimum washout period of prior anticancer therapy as specified by the protocol
- Prior allogeneic haematopoietic stem cell transplantation
- History of solid organ transplant
- Major surgery within 4 weeks of the start of study drug.
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 |
|---|---|---|
| TazemetostatAlso: IPN60200Orally, twice daily in continuous 28-day cycles. | Drug | Arm 1-Tazemetostat plus tafasitamab-cxix (CD19 Ab)/lenalidomide, Arm 2-Tazemetostat plus lenalidomide, Arm 3- Tazemetostat plus BTKi (acalabrutinib), Arm 4-Tazemetostat plus CD38 mAbPD (daratumumab/pomalidomide/dexamethasone), Arm 5- Tazemetostat plus CD20/CD3 BsAb (mosunetuzumab) |
| TafasitamabIntravenously, 12 mg/kg, once daily on Cycle 1: Days 1, 4, 8, 15 and 22 of the 28-day cycle. Cycles 2 and 3: Days 1, 8, 15 and 22 of each 28-day cycle. Cycle 4 and beyond: Days 1 and 15 of each 28-day cycle. | Drug | Arm 1-Tazemetostat plus tafasitamab-cxix (CD19 Ab)/lenalidomide |
| LenalidomideOrally, 10 mg or 20 mg based on kidney function, once daily from Days 1 to 21 of continuous 28-day cycles for up to 12 cycles. | Drug | Arm 1-Tazemetostat plus tafasitamab-cxix (CD19 Ab)/lenalidomide, Arm 2-Tazemetostat plus lenalidomide |
| AcalabrutinibAlso: Bruton tyrosine kinase inhibitorOrally, 100 mg, twice daily. | Drug | Arm 3- Tazemetostat plus BTKi (acalabrutinib) |
| Daratumumab (Intravenously)Intravenously, 16 mg/kg actual body weight, once daily on Cycles 1 and 2: Days 1, 8, 15 and 22 of the 28-day cycle. Cycles 3 through 6: Days 1 and 15 each 28-day cycle. Cycle 7 and beyond: Day 1 of each 28-day cycle. | Drug | Arm 4-Tazemetostat plus CD38 mAbPD (daratumumab/pomalidomide/dexamethasone) |
| MosunetuzumabSubcutaneously, step-up doses on Cycle 1 Days 1 (5 mg), 8 (45 mg) and 15 (45 mg) and then 45 mg from Cycle 2 through 12 on Day 1 of the 28-day cycle. | Drug | Arm 5- Tazemetostat plus CD20/CD3 BsAb (mosunetuzumab) |
| Daratumumab (Subcutaneously)Subcutaneously, 1800 mg, once daily on Cycles 1 and 2: Days 1, 8, 15 and 22 of the 28-day cycle. Cycles 3 through 6: Days 1 and 15 each 28-day cycle. Cycle 7 and beyond: Day 1 of each 28-day cycle. | Drug | Arm 4-Tazemetostat plus CD38 mAbPD (daratumumab/pomalidomide/dexamethasone) |
| Hyaluronidase-FihjSubcutaneously, 30,000 units, once daily on Cycles 1 and 2: Days 1, 8, 15 and 22 of the 28-day cycle. Cycles 3 through 6: Days 1 and 15 each 28-day cycle. Cycle 7 and beyond: Day 1 of each 28-day cycle. | Drug | Arm 3- Tazemetostat plus BTKi (acalabrutinib) |
| PomalidomideOrally, 4 mg, once daily on Days 1 to 21 of continuous 28-day cycles. | Drug | Arm 4-Tazemetostat plus CD38 mAbPD (daratumumab/pomalidomide/dexamethasone) |
| Dexamethasone 20mgOrally, 20 mg or 40 mg, once daily on Days 1, 8, 15, and 22 of continuous 28-day cycles. | Drug | Arm 4-Tazemetostat plus CD38 mAbPD (daratumumab/pomalidomide/dexamethasone) |
Primary outcome
Phase 1b: Recommended Phase 2 Dose (RP2D) of tazemetostat in combination with each partner drug
Time frame: Evaluated for DLTs during the first 28-day cycle. The RP2D for Phase 2 for each arm will be selected at the end of that arm's experience in Phase 1b
The safety and tolerability of tazemetostat in combination with each partner drug in participants with R/R malignancies will be evaluated. RP2D of tazemetostat for further evaluation in phase 2 will be selected as assessed by the occurrence of treatment-emergent dose-limiting toxicities (DLTs) and adverse events (AEs).
Phase 2: Objective Response Rate (ORR)
Time frame: Time from the date of first dose of study drug to the time of response, assessed up to 24 months.
Overall response rate is defined as proportion of participants with a best response of at least partial remission (including partial remission and complete remission for participants with non-Hodgkin lymphoma in Arms 1, 2, 3, or 5 or partial remission, complete remission, stringent complete response, or very good partial response).
8 secondary outcomes
Phase 2: Progression Free Survival (PFS)
Time frame: Up to 24 months.
Time to response (TTR)
Time frame: Up to 24 months
Phase 2: Duration of Response (DOR)
Time frame: Up to 24 months
Phase 2: Disease control rate (DCR)
Time frame: Up to 24 months
Phase 2: Overall Survival (OS)
Time frame: Up to 24 months
Time to next treatment (TTNT)
Time frame: Up to 24 months
Percentage of participants with Treatment Emergent Adverse Event (TEAEs)
Time frame: Up to 24 months
Percentage of participants with clinically significant changes in laboratory parameters
Time frame: Up to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
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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.
Ipsen Medical Director study director
Ipsen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tazemetostat, Tafasitamab and Lenalidomide in people with Relapsed Hematologic Malignancy and Refractory Hematologic Malignancy, run by Epizyme, Inc. at 3 sites 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 7 inclusion and 26 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: withdrawn, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Phase 1b: Recommended Phase 2 Dose (RP2D) of tazemetostat in combination with each partner drug (time frame: Evaluated for DLTs during the first 28-day cycle. The RP2D for Phase 2 for each arm will be selected at the end of that arm's experience in Phase 1b). The study lists 2 primary outcomes in all. 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 15 Aug 2023.