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Relapsed/Refractory Mantle Cell LymphomaPhase 1NCT01838434

Lenalidomide With or Without Idelalisib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

A Phase 1 study testing lenalidomide and idelalisib in people with Relapsed/Refractory Mantle Cell Lymphoma, run by Alliance for Clinical Trials in Oncology at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Phase I/II trial studies the safety and effectiveness of lenalidomide with or without idelalisib. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory Mantle Cell Lymphoma
What is being tested?
lenalidomide and idelalisib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
4 sitesUnited States
Study dates
17 Oct 2013to 1 May 2017
Phase
Phase 1
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
  1. Documentation of Disease:
  2. Histologically documented mantle cell lymphoma, with the following immunophenotypic characteristics: cluster of differentiation (CD)5+, (CD)23-, cyclin D1+; this may be from an initial diagnostic biopsy, or one obtained at time of relapse
  3. Institutional flow cytometry or immunohistochemistry must confirm CD5 antigen expression, lack of CD23 antigen expression, and expression of cyclin D1.
  4. Variant cases of mantle cell lymphoma will be eligible to participate after discussion and joint agreement between the PI, the Pathology Committee Chair, and the Lymphoma Committee Chair. Variant cases may include (but are not limited to) lack of Cyclin D1 expression (ie cases with Cyclin D2 or Cyclin D3 expression), CD23 negativity (if all other criteria are met), or alternative translocations leading to Cyclin D1 expression.
  5. Prior Treatment - Patients must have prior treatment with at least one regimen, which may have been single agent or multi-agent, and consisted of traditional cytotoxic agents and/or biologic agents. Patient must not have received prior idelalisib or lenalidomide therapy. Patient must have progressive disease or refractory disease. Refractory disease will be defined as stable disease (SD) or progressive disease (PD) as best response to prior therapy. Progressive disease will be defined as complete response (CR) or partial response (PR) as initial response to prior therapy followed by disease progression within 6 months. Prior autologous, but not allogeneic, stem cell transplant is allowed. No corticosteroids within two weeks prior to study, except for maintenance therapy for a non-malignant disease. Maintenance therapy dose may not exceed 20 mg/day prednisone or equivalent.
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status - Patients must have ECOG performance status of 0-2.
  7. Measurable Disease must be present either on imaging studies. Non-measurable disease alone is not acceptable. Any tumor mass > 1 cm by computed tomography (CT), magnetic resonance imaging (MRI), or conventional radiograph is acceptable. Lesions that are considered non-measurable include the following:
  8. Bone lesions (lesions, if present, should be noted)
  9. Ascites
  10. Pleural/pericardial effusion
  11. Lymphangitis cutis/pulmonis
  12. Bone marrow (involvement by non-Hodgkin lymphoma should be noted)
  13. Central Nervous System (CNS) Involvement - Patients must have no known CNS involvement by lymphoma.
  14. Human Immunodeficiency Virus (HIV) Infection - Patients with HIV infection are eligible, provided they meet the following:
  15. CD4+ cell count > 350/mm3
  16. Treatment sensitive HIV and, if on anti-HIV therapy, HIV viral load < 50 copies/mm3
  17. No history of Acquired Immune Deficiency Syndrome (AIDS)-defining conditions or other HIV related illness
  18. No concurrent zidovudine or stavudine because of overlapping toxicities with protocol therapy
  19. Patients with known HIV positivity must have CD4 assessment and viral load at baseline and every 6 months while on study.
  20. Pregnancy and Nursing Status - Patients must be non-pregnant and non-nursing. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to registration. Further, they must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy. A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy, or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time preceding 24 consecutive months).
  21. Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) - Patients with a recent history (within 3 months of study entry) of DVT/PE are not eligible. Patients with a distant history (greater than 3 months before study entry) of DVT/PE are eligible, but must receive either prophylactic aspirin or low molecular weight heparin, unless contraindicated.
  22. Congestive Heart Failure - Patients must have no New York Heart Association (NYHA) Class III or Class IV congestive heart failure at study entry.
  23. Myocardial Infarction - Patients must have no myocardial infarction within 6 months prior to study entry.
  24. Hepatitis - Patients must not have known positivity for hepatitis B, as evidenced by + HBsAg or +anti-HBc, and must not have known history of hepatitis C.
  25. Patients must be ≥ 18 years of age.
  26. Cytochrome P450 3A4 (CYP3A4) Strong Inducers and Inhibitors - Patients must not be on strong CYP3A4 inhibitors and/or inducers.
  27. The following strong inhibitors are prohibited: indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole,nefazodone
  28. The following strong inducers are prohibited: carbamazepine, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, St. John's Wort, troglitazone
  29. Required Initial Laboratory Values:
  30. ANC ≥ 1,000/µL, ≥ 500/µL if marrow involvement
  31. Platelets ≥ 75,000/µL
  32. Creatinine ≤ 1.5 x ULN, and estimated creatinine clearance ≥ 60 mL/min (patients on dialysis not eligible), unless attributable to non-Hodgkin lymphoma
  33. Total bilirubin ≤ 2 x ULN, unless attributable to non-Hodgkin lymphoma or Gilbert's disease

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University of Chicago

    Chicago, Illinois, 60637

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase I/Randomized Phase II Trial of Idelalisib and Lenalidomide in Patients With Relapsed/Refractory Mantle Cell Lymphoma

This Phase I/II trial studies the safety and effectiveness of lenalidomide with or without idelalisib. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Idelalisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether lenalidomide is more effective with or without idelalisib in treating mantle cell lymphoma.

Read the detailed description

A notice of temporary accrual suspension for Alliance A051201 was issued on 1/28/14. The study was suspended to new patient accrual until a protocol amendment was finalized, which provided revised treatment instructions. The study was reactivated on 4/22/14 including the removal of the rituximab treatment arm.

Outline: This is a phase I, dose-escalation study followed by a phase II study.

The phase I treatment plan includes the following:

  1. Lenalidomide will be tested at sequential dose levels in a standard 3+3 design.
  2. Dose Level 0 = 15mg/day for days 1-21 every 28 days
  3. Dose Level 1 = 20mg/day for days 1-21 every 28 days and
  4. Dose Level 2 = 25mg/day for days 1-21 every 28 days. Patients can continue lenalidomide for up to 48 weeks (12 cycles) of treatment.
  5. Idelalisib will be orally administered starting at 150 mg twice daily for continuous 28-day cycles until progression, intolerance, or patient/physician discretion. The dose is the same in dose levels 0, 1, and 2.

Patients are randomized to 1 of 2 treatment arms in the Phase II treatment plan. The primary and secondary objectives for this study are:

  1. Phase I Primary Objective: To determine the safety and tolerability of the combination of lenalidomide with idelalisib in sequential dose cohorts.
  2. Phase II Primary Objective: To determine the progression-free survival (PFS) of the combination of lenalidomide with or without idelalisib in a randomized phase II design.
  3. Phase II Secondary Objectives:
  4. To determine the overall response rate (ORR), complete response rate (CR), and overall survival (OS) of the combination of lenalidomide with or without idelalisib in a randomized phase II design.
  5. To determine the prognostic and/or predictive significance of proliferation markers and cell cycle components in patients with relapsed/refractory mantle cell lymphoma (MCL) treated with idelalisib and lenalidomide.
  6. To determine whether phosphorylated protein kinase B (pAKT) expression levels are correlated with response to idelalisib plus lenalidomide.
  7. To determine whether Notch activation as assessed by notch homolog 1, translocation- association (NOTCH1) intracellular domain (ICD) immunohistochemistry (IHC) correlates with NOTCH1 mutational status and outcome in MCL patients treated with idelalisib and lenalidomide.
  8. To determine whether sex determining region Y-box 11 (SOX11) expression correlates with response in patients with relapsed/refractory MCL treated with idelalisib and lenalidomide.
  9. To correlate cereblon (CRBN) expression with response in patients with relapsed/refractory MCL treated with idelalisib and lenalidomide.
  10. To evaluate several plasma cytokines and correlate observed changes to objective response rates.
Being tested
lenalidomide, idelalisib
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01838434
Study groupRoleWhat they receive
lenalidomide (Phase II)Active comparatorLenalidomide will be administered orally at 20 mg daily on days 1-21, repeated every 28 days for a maximum of 12 cycles (48 weeks). (Phase II)
Receives: Drug: lenalidomide
lenalidomide and idelalisib (Phase II)ExperimentalLenalidomide will be administered orally and daily on days 1-21, repeated every 28 days for a maximum of 12 cycles (48 weeks). Idelalisib will be orally administered for continuous 28-day cycles until progression, intolerance, or patient/physician discretion. Dosing will be determined by the Phase I portion of the study. (Phase II)
Receives: Drug: lenalidomide; Drug: idelalisib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) of idelalisib and lenalidomide, determined according to incidence of dose-limiting toxicity (DLT) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)

    Measured: 28 days

  2. Progression Free Survival (PFS) of the combination of lenalidomide, with or without idelalisib (Phase II)

    Measured: Time between registration and disease progression or death, assessed up to 2 years

Secondary outcomes (2)

  1. Overall survival (OS) (Phase II)

    Measured: Up to 2 years

  2. Overall response rate (partial or complete response) (Phase II)

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2013 (estimated)
  2. Study start17 Oct 2013
  3. Primary completion30 Sep 2014
  4. Study completion1 May 2017

Resources

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
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01838434
Sponsor's protocol ID
A051201
Other IDs
NCI-2012-01734, U10CA031946
Status last verified
Jun 2026
First submitted
19 Apr 2013
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Smith SM, Pitcher BN, Jung SH, Bartlett NL, Wagner-Johnston N, Park SI, Richards KL, Cashen AF, Jaslowski A, Smith SE, Cheson BD, Hsi E, Leonard JP. Safety and tolerability of idelalisib, lenalidomide, and rituximab in relapsed and refractory lymphoma: the Alliance for Clinical Trials in Oncology A051201 and A051202 phase 1 trials. Lancet Haematol. 2017 Apr;4(4):e176-e182. doi: 10.1016/S2352-3026(17)30028-5. Epub 2017 Mar 15.

    PubMed 28314699

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lenalidomide and idelalisib in people with Relapsed/Refractory Mantle Cell Lymphoma, run by Alliance for Clinical Trials in Oncology at 4 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?

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: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum tolerated dose (MTD) of idelalisib and lenalidomide, determined according to incidence of dose-limiting toxicity (DLT) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) (time frame: 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?

On the ClinicalTrials.gov record for NCT01838434, which also lists 1 linked publication.

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 16 Jun 2026.

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