Indolent LymphomaPhase 1/2GP-1NCT07441954
Pomalidomide Combined With Obinutuzumab in the Treatment of Patients With Relapsed/Refractory Indolent Lymphoma
A Phase 1/2 study testing Induction therapy of GP(Pomalidomide+Obinutuzumab） and maintenance therapy of GP(Pomalidomide+Obinutuzumab） in people with Indolent Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
To explore the maximum tolerated dose (MTD) of pomalidomide in combination with obinutuzumab in patients with relapsed/refractory indolent lymphomas (including follicular lymphoma, marginal zone lymphoma, and chronic lymphocytic leukemia/small lymphocytic lymphoma) treated with the pomalidomide plus obinutuzumab… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indolent Lymphoma
- What is being tested?
- Induction therapy of GP(Pomalidomide+Obinutuzumab） and maintenance therapy of GP(Pomalidomide+Obinutuzumab）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2026to 31 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years old, regardless of gender;
- Histopathologically confirmed CD20+ indolent lymphoma (FL, MZL, or SLL), WHO grade 1-3a;.
- Relapsed or refractory disease after at least one prior line of therapy;.
- ECOG-PS 0-2;
- At least one measurable lesion;
- Bone marrow hematopoietic function is basically normal. Complete blood count: white blood cell count >3000/uL, absolute neutrophil count ≥1.5×10^9/L (use of granulocyte colony-stimulating factor is permitted), platelet count ≥75×10^9/L (transfusion is allowed to achieve this minimum platelet count), hemoglobin ≥9.0g/dL (prior red blood cell transfusion or use of recombinant human erythropoietin is permitted). If abnormal peripheral blood indices are caused by lymphoma infiltration of bone marrow or spleen, the investigator may exercise discretion in determining eligibility for enrollment.
Show all 10Show fewer
- Normal function of major organs: Liver function: serum bilirubin ≤2.0×ULN, serum ALT and AST ≤2.5×ULN; Renal function: creatinine clearance >30mL/min;.
- The investigator judged that the expected survival period was ≥3 months;
- The patient was fully informed and signed the informed consent form;.
- Female subjects must use effective contraception, not be pregnant, and agree to practice contraception during the trial and after the study ends. Male subjects must agree to practice contraception during the trial and for 30 days after the last treatment.
Who cannot join
- Any other type of lymphoma, including Burkitt lymphoma;
- The investigator confirms that the patient may progress to aggressive lymphoma.
- Patients with contraindications or allergies to the investigational drug.
- History of VTE or cerebral infarction prior to treatment;.
- Patients who have undergone major surgery within 30 days prior to enrollment that may significantly impair physical condition or increase the risk of thrombosis, or who have scheduled surgery during the study period. Subjects planning to undergo minor surgical procedures under local anesthesia that do not significantly affect physical condition or markedly increase thrombosis risk may participate in the study.
- Patients with uncontrolled or severe cardiovascular diseases, including myocardial infarction within 3 months prior to enrollment, unstable coronary artery disease, uncontrolled chronic congestive heart failure, Class III-IV heart failure as defined by the New York Heart Association (NYHA), or clinically significant pericardial disease;.
Show all 18Show fewer
- Uncontrolled hypertension.
- Uncontrolled diabetes.
- Uncontrolled active infection, or acute active infection, requiring systemic use of antibiotics, antiviral or antifungal medications within two weeks prior to the first dose.
- HIV-positive.
- Active hepatitis B or C.
- History of other malignancies within 3 years prior to the first study drug administration.
- Any clinically significant medical condition or disorder that the investigator considers may affect compliance with the experimental protocol or the subject's ability to provide informed consent.
- The subject is a pregnant or lactating female.
- Patients with severe physical or mental illnesses that may interfere with participation in this clinical study as determined by the protocol or investigator's judgment; or conditions such as drug abuse, medical, psychological, or social circumstances that may affect the subject's participation or evaluation of study results.
- Patients currently receiving other investigational drug treatments.
- Participants who have taken part in other clinical trials within one month.
- Any other patients deemed ineligible for inclusion by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Phase I/II Clinical Study of Pomalidomide Combined With Obinutuzumab in the Treatment of Patients With Relapsed/Refractory Indolent Lymphoma.
To explore the maximum tolerated dose (MTD) of pomalidomide in combination with obinutuzumab in patients with relapsed/refractory indolent lymphomas (including follicular lymphoma, marginal zone lymphoma, and chronic lymphocytic leukemia/small lymphocytic lymphoma) treated with the pomalidomide plus obinutuzumab combination regimen, and to determine the recommended phase II dose (RP2D); concurrently evaluating the efficacy and safety of pomalidomide combined with obinutuzumab in patients with relapsed/refractory indolent lymphomas.
Read the detailed description
Most indolent B-cell lymphomas have a prolonged natural course with frequent disease relapses, requiring multiple lines of therapy. There is currently no unified standard regimen for relapsed indolent lymphomas, and treatment options are limited for patients who develop resistance to the R2 regimen. Obinutuzumab is a next-generation CD20 monoclonal antibody, while pomalidomide, as a third-generation immunomodulatory drug (IMiDs), exhibits stronger immunomodulatory activity compared to lenalidomide.The Phase I trial evaluated the maximum tolerated dose（MTD） and recommended Phase II dose（RP2D） of the GP regimen (obinutuzumab combined with pomalidomide) in treating relapsed/refractory indolent lymphoma. The Phase II trial assessed the GP regimen, including both induction and maintenance therapy phases, aiming to enhance treatment efficacy, survival rates, and tolerability, thereby providing a novel therapeutic approach for this disease category.
- Conditions
- Indolent Lymphoma
- Being tested
- Induction therapy of GP(Pomalidomide+Obinutuzumab）, maintenance therapy of GP(Pomalidomide+Obinutuzumab）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction therapy of GP(Pomalidomide+Obinutuzumab）Drug
Phase 1: Dose Escalation Phase. Obinutuzumab administered at 1000 mg on days 1, 8, and 15 (Cycle 1), and day 1 (Cycles 2-6), with a 28-day cycle. Pomalidomide is administered in three dose groups (2 mg, 3 mg, 4 mg) on days 1-21. Dose-limiting toxicity (DLT) is observed during the first cycle to determine the recommended Phase II dose (RP2D).
2、Phase 2: Dose Expansion Phase. Induction Therapy: Obinutuzumab administered at 1000 mg on days 1, 8, and 15 (Cycle 1), and day 1 (Cycles 2-6), with pomalidomide at RP2D on days 1-21, in 28-day cycles for 6 cycles.
maintenance therapy of GP(Pomalidomide+Obinutuzumab）Drug
Maintenance Therapy ：Pomalidomide: For complete response (CR) patients, half of the RP2D dose; for PR patients, full RP2D dose, on days 1-21 (Cycles 7-18). Obinutuzumab: 1000 mg administered on day 1 of every 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| Induction therapy and maintenance therapy of GP | Experimental | 1. Phase 1: Dose Escalation Phase. Obinutuzumab administered at 1000 mg on days 1, 8, and 15 (Cycle 1), and day 1 (Cycles 2-6), with a 28-day cycle. Pomalidomide is administered in three dose groups (2 mg, 3 mg, 4 mg) on days 1-21. Dose-limiting toxicity (DLT) is observed during the first cycle to determine the recommended Phase II dose (RP2D).
2. Phase 2: Dose Expansion Phase. Induction Therapy: Obinutuzumab administered at 1000 mg on days 1, 8, and 15 (Cycle 1), and day 1 (Cycles 2-6), with pomalidomide at RP2D on days 1-21, in 28-day cycles for 6 cycles.
Maintenance Therapy ：Pomalidomide: For complete response (CR) patients, half of the RP2D dose; for PR patients, full RP2D dose, on days 1-21 (Cycles 7-18). Obinutuzumab: 1000 mg administered on day 1 of every 2 cycles Receives: Drug: Induction therapy of GP(Pomalidomide+Obinutuzumab）; Drug: maintenance therapy of GP(Pomalidomide+Obinutuzumab） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase II Dose (RP2D)
The drug dose for Phase 2 clinical trials was determined through dose escalation in Phase 1 clinical trials to identify the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD).
Measured: day 28 (each cycle is 28 days)
Phase 2 : Objective response rate，ORR
defined as the proportion of patients with complete or partial response as assessed by response to induction therapy.
Measured: Up to the end of 6 cycles of treatment(each cycle is 28 days)
Secondary outcomes (4)
complete response rate，CRR
Measured: Up to 24 weeks (each cycle is 28 days)
progression-free survival，PFS
defined as the time from the start of treatment to disease progression or death due to any cause
Measured: through study completion, an average of 5 year
Overall survival，OS
Defined as the time from enrollment to death for any cause.
Measured: through study completion, an average of 5 year
Adverse event rate
Measured: through maintenance therapy completion, an average of 2 years (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start20 Mar 2026 (estimated)
- Primary completion5 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indolent LymphomaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441954
- Sponsor's protocol ID
- IIT2025083
- Acronym
- GP-1
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Phase I/II Clinical Study of Pomalidomide Combined With Obinutuzumab in the Treatment of Patients With Relapsed/Refractory Indolent Lymphoma.
- ClinicalTrials.gov ID
- NCT07441954
- Acronym / sponsor ID
- GP-1 / IIT2025083
- Conditions
- Indolent Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 5 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Mar 2026 (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.
To explore the maximum tolerated dose (MTD) of pomalidomide in combination with obinutuzumab in patients with relapsed/refractory indolent lymphomas (including follicular lymphoma, marginal zone lymphoma, and chronic lymphocytic leukemia/small lymphocytic lymphoma) treated with the pomalidomide plus obinutuzumab combination regimen, and to determine the recommended phase II dose (RP2D); concurrently evaluating the efficacy and safety of pomalidomide combined with obinutuzumab in patients with relapsed/refractory indolent lymphomas.
Detailed description
Most indolent B-cell lymphomas have a prolonged natural course with frequent disease relapses, requiring multiple lines of therapy. There is currently no unified standard regimen for relapsed indolent lymphomas, and treatment options are limited for patients who develop resistance to the R2 regimen. Obinutuzumab is a next-generation CD20 monoclonal antibody, while pomalidomide, as a third-generation immunomodulatory drug (IMiDs), exhibits stronger immunomodulatory activity compared to lenalidomide.The Phase I trial evaluated the maximum tolerated dose（MTD） and recommended Phase II dose（RP2D） of the GP regimen (obinutuzumab combined with pomalidomide) in treating relapsed/refractory indolent lymphoma. The Phase II trial assessed the GP regimen, including both induction and maintenance therapy phases, aiming to enhance treatment efficacy, survival rates, and tolerability, thereby providing a novel therapeutic approach for this disease category.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction therapy and maintenance therapy of GP | Experimental | Drug: Induction therapy of GP(Pomalidomide+Obinutuzumab）, Drug: maintenance therapy of GP(Pomalidomide+Obinutuzumab）1. Phase 1: Dose Escalation Phase. Obinutuzumab administered at 1000 mg on days 1, 8, and 15 (Cycle 1), and day 1 (Cycles 2-6), with a 28-day cycle. Pomalidomide is administered in three dose groups (2 mg, 3 mg, 4 mg) on days 1-21. Dose-limiting toxicity (DLT) is observed during the first cycle to determine the recommended Phase II dose (RP2D). 2. Phase 2: Dose Expansion Phase. Induction Therapy: Obinutuzumab administered at 1000 mg on days 1, 8, and 15 (Cycle 1), and day 1 (Cycles 2-6), with pomalidomide at RP2D on days 1-21, in 28-day cycles for 6 cycles. Maintenance Therapy ：Pomalidomide: For complete response (CR) patients, half of the RP2D dose; for PR patients, full RP2D dose, on days 1-21 (Cycles 7-18). Obinutuzumab: 1000 mg administered on day 1 of every 2 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years old, regardless of gender;
- Histopathologically confirmed CD20+ indolent lymphoma (FL, MZL, or SLL), WHO grade 1-3a;.
- Relapsed or refractory disease after at least one prior line of therapy;.
- ECOG-PS 0-2;
- At least one measurable lesion;
Key exclusion criteria (18 listed)
- Any other type of lymphoma, including Burkitt lymphoma;
- The investigator confirms that the patient may progress to aggressive lymphoma.
- Patients with contraindications or allergies to the investigational drug.
- History of VTE or cerebral infarction prior to treatment;.
- Patients who have undergone major surgery within 30 days prior to enrollment that may significantly impair physical condition or increase the risk of thrombosis, or who have scheduled surgery during the study period. Subjects planning to undergo minor surgical procedures under local anesthesia that do not significantly affect physical condition or markedly increase thrombosis risk may participate in the study.
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 |
|---|---|---|
| Induction therapy of GP(Pomalidomide+Obinutuzumab）Phase 1: Dose Escalation Phase. Obinutuzumab administered at 1000 mg on days 1, 8, and 15 (Cycle 1), and day 1 (Cycles 2-6), with a 28-day cycle. Pomalidomide is administered in three dose groups (2 mg, 3 mg, 4 mg) on days 1-21. Dose-limiting toxicity (DLT) is observed during the first cycle to determine the recommended Phase II dose (RP2D). 2、Phase 2: Dose Expansion Phase. Induction Therapy: Obinutuzumab administered at 1000 mg on days 1, 8, and 15 (Cycle 1), and day 1 (Cycles 2-6), with pomalidomide at RP2D on days 1-21, in 28-day cycles for 6 cycles. | Drug | Induction therapy and maintenance therapy of GP |
| maintenance therapy of GP(Pomalidomide+Obinutuzumab）Maintenance Therapy ：Pomalidomide: For complete response (CR) patients, half of the RP2D dose; for PR patients, full RP2D dose, on days 1-21 (Cycles 7-18). Obinutuzumab: 1000 mg administered on day 1 of every 2 cycles | Drug | Induction therapy and maintenance therapy of GP |
Primary outcome
Recommended Phase II Dose (RP2D)
Time frame: day 28 (each cycle is 28 days)
The drug dose for Phase 2 clinical trials was determined through dose escalation in Phase 1 clinical trials to identify the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD).
Phase 2 : Objective response rate，ORR
Time frame: Up to the end of 6 cycles of treatment(each cycle is 28 days)
defined as the proportion of patients with complete or partial response as assessed by response to induction therapy.
4 secondary outcomes
complete response rate，CRR
Time frame: Up to 24 weeks (each cycle is 28 days)
progression-free survival，PFS
Time frame: through study completion, an average of 5 year
Overall survival，OS
Time frame: through study completion, an average of 5 year
Adverse event rate
Time frame: through maintenance therapy completion, an average of 2 years (each cycle is 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Indolent Lymphoma
Active, not recruitingPhase 1/2
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
DLBCL, High-grade B-cell Lymphoma (HGBCL)
Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Hematologic Cancer
Active, not recruitingPhase 1/2
A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma
Follicular Lymphoma, Marginal Zone Lymphoma
Active, not recruitingPhase 1
Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma
Active, not recruitingPhase 2/3
Testing the Addition of a New Anti-cancer Drug, Venetoclax, to Usual Chemotherapy for High Grade B-cell Lymphomas
Diffuse Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Induction therapy of GP(Pomalidomide+Obinutuzumab） and maintenance therapy of GP(Pomalidomide+Obinutuzumab） in people with Indolent Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China.
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 18 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: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuhua Yi, Dr (+86-022-23909106, yishuhua@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase II Dose (RP2D) (time frame: day 28 (each cycle is 28 days)). 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 2 Mar 2026.