Mantle Cell LymphomaPhase 2NCT03478514
Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma
A Phase 2 study testing Palbociclib and Ibrutinib in people with Mantle Cell Lymphoma and B Cell Lymphoma, run by Alliance Foundation Trials, LLC. at 9 sites in United States.
Trial summary
The proposed study is a single-arm, multi-center, open-label phase II study of the combination of palbociclib and ibrutinib in patients with previously treated mantle cell lymphoma to evaluate the efficacy of this combination, with the primary objective of the study being to assess median PFS and the secondary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma, B Cell Lymphoma
- What is being tested?
- Palbociclib and Ibrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 9 sitesUnited States
- Study dates
- 11 Sep 2018to 30 Jul 2027
- Phase
- Phase 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
- Subjects must have histologically or cytologically confirmed MCL as defined by the World Health Organization. All patients must have either t(11;14) by karyotype or fluorescent in-situ hybridization (FISH) or positive immunohistochemistry (IHC) for cyclin D1.
- Subjects must have measurable disease defined as at least one tumor lesion of at least 1.5 cm by CT or MRI, PET positive lesion(s) or a peripheral blood CD5+, CD19+ lymphocyte count of at least 5,000 cells/µL.
- Subjects must have received at least one prior systemic therapy.
- Subjects who have received prior autologous stem cell transplant are eligible. Patients that have undergone prior allogeneic stem cell transplant will only be eligible if the patient is no longer taking immunosuppressive therapy and there are no significant ongoing transplant-related adverse effects.
- Subjects must be age ≥ 18 years
- ECOG performance status ≤ 2
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- Patients must have normal organ and marrow function as defined below:
- Laboratory Values:
- ANC ≥ 1000 cells/μL, unless bone marrow involvement in MCL, then ANC >500 cells/μL;
- Platelets ≥ 75,000 cells/μL, unless bone marrow involvement in MCL, then platelets >30,000 cells/μL;
- Calculated creatinine clearance ≥30mL/min;
- AST or ALT ≤ 2.5x ULN;
- Total bilirubin ≤ 1.5x ULN;
- QTc ≤ 480 ms
- Subjects must be able to provide written, informed consent
- Subjects must have recovered from adverse events to ≤ grade 1 from prior therapies
- Subjects must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption
- Subjects may be receiving prednisone at a maximum dose of 20 mg orally daily for symptom control.
- Serum or urine pregnancy test must be negative within 7 days of starting study treatment in women of childbearing potential. Women of childbearing potential and men with female partners who are able to become pregnant are required to use a highly effective form of barrier contraception for the duration of the study and for 90 days after the last dose of study drug. Adequate contraception is defined as abstinence or two forms non hormonal contraception, which is a combination of two forms of the following:
- Condom with spermicidal foam/gel/cream/suppository
- occlusive cap (diaphragm or cervical vault caps) with spermicidal
- non hormonal intrauterine device (IVD)
- No evidence of active hepatitis B or C infections (i.e., no positive serology for anti-HBc or anti-HCV antibodies)
- HBV seropositive patients (HBsAg +) are eligible if they are closely monitored for evidence of active HBV infection by HBV DNA testing and receive suppressive therapy with lamivudine or other HBV suppressive therapy until 6 months after the last rituximab dose.
- Patients with HIV infection are eligible, provided they meet the following:
- No evidence of coinfection with hepatitis B or C
- CD4+ cell count ≥ 400/mm3
- No evidence of resistant strains of HIV
- If not on anti-HIV therapy, HIV viral load < 10,000 copies HIV RNA/mL If on anti-HIV therapy, HIV viral load < 50 copies HIV RNA/mL
- No history of AIDS-defining conditions
- No use of strong CYP3A4/5 inhibitors or inducers
Who cannot join
- Subjects that have received prior CDK4/6 inhibitor will not be eligible.
- Subjects that have received any prior BTK inhibitor > 90 days prior to enrollment will not be eligible.
- Subjects with known or suspected CNS involvement.
- Concurrent therapy with other investigational products.
- History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib.
- Subjects receiving any medications or substances that are strong or moderate inhibitors or strong inducers of CYP3A isoenzymes within 7 days of starting study treatment (See Appendix II).
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- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subjects with myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities are not eligible. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant.
- Pregnant women, or women of childbearing potential without a negative pregnancy test (serum or urine) within 7 days prior to registration, irrespective of the method of contraception used, are excluded from this study because the effect of palbociclib on a developing fetus is unknown. Breastfeeding should be discontinued prior to study entry.
- Subjects must agree to use barrier contraceptive methods throughout the study period up until at least 90 days post last palbociclib dose.
- Subjects with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis, etc.
- Subjects with another active malignancy that limits survival.
- Subjects with a bleeding diathesis are not eligible.
- Subjects with transfusion-dependent thrombocytopenia are not eligible.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
University of North Carolina
Chapel Hill, North Carolina, 27599
Medical University of South Carolina - Hollings Cancer Center
Charleston, South Carolina, 29425
Ohio State University
Columbus, Ohio, 43210
City of Hope National Medical Center
Duarte, California, 91010
Weill Cornell Medical College
New York, New York, 10065
St. Joseph Mercy Hospital Cancer Care Center
Ypsilanti, Michigan, 48197
About this study
Official title: A Phase II Study of Palbociclib (PD-0332991) in Combination With Ibrutinib in Patients With Previously Treated Mantle Cell Lymphoma
The proposed study is a single-arm, multi-center, open-label phase II study of the combination of palbociclib and ibrutinib in patients with previously treated mantle cell lymphoma to evaluate the efficacy of this combination, with the primary objective of the study being to assess median PFS and the secondary objectives to include ORR, CR, DOR, OS and toxicity. Subjects will be enrolled and treated with palbociclib and ibrutinib with each cycle of therapy being 28 days. Treatment will be based on the recommended phase II dose (RP2D) from the phase I combination trial.
Read the detailed description
Treatment will consist of:
- Palbociclib administered at 100 mg oral once daily for 21 days on followed by 7 days off
- Ibrutinib administered at 560 mg oral continuously
Patients will continue to receive study drugs until disease progression, unacceptable toxicity, or withdrawal of consent. If at any time one of the agents is held due to toxicity, the other agent may be continued in those patients who are receiving clinical benefit.
Response will be assessed by PET/CT and/or CT every 3 cycles while on therapy for the first year and then every 6 cycles thereafter until disease progression or at the investigator's discretion if otherwise medically indicated. A PET will be required to confirm CR. A bone marrow biopsy will be performed in patients with bone marrow involvement at the start of therapy to confirm complete response once patients have otherwise met criteria for CR.
- Conditions
- Mantle Cell Lymphoma, B Cell Lymphoma
- Being tested
- Palbociclib, Ibrutinib
- Keywords
- mantle cell lymphoma, B-cell lymphoma, palbociclib
- Medical subject headings
- Lymphoma, Mantle-Cell, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called Ibrance; PD-0332991
Taken at 100 mg once daily for 21 days, followed by 7 days off
IbrutinibDrug
Also called Imbruvica
560 mg taken orally all patients throughout the study
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All patients will receive palbociclib at 100 mg oral once a day for 21 days, followed by 7 days off.
Ibrutinib will be administered at 560 mg oral continuously. Receives: Drug: Palbociclib; Drug: Ibrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Time interval between registration and progression or death
Measured: 42 months
Secondary outcomes (5)
Overall survival
time from registration to death due to any cause
Measured: 42 months
Duration of response
Time from documentation of tumor response to disease progression
Measured: 42 months
Overall Response Rate
Proportion of patients with reduction in tumor burden of a predefined amount
Measured: 42 Months
Complete Response
Disappearance of all non-target lesions and normalization of tumor marker level
Measured: 42 Months
Toxicity: Incidence and severity of adverse events by summaries of toxicity data/contingency tables
Evaluation of incidence and severity of adverse events by summaries of toxicity data/contingency tables
Measured: 42 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start11 Sep 2018
- Primary completion19 Dec 2025
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mantle Cell LymphomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The proposed study is a single-arm, multi-center, open-label phase II study of the combination of palbociclib and ibrutinib in patients with previously treated mantle cell lymphoma.
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance Foundation Trials, LLC.
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Evanthia Galanis, MD, Principal investigator, Alliance Foundation Trials, LLC.Kami Maddocks, MD, Study chair, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478514
- Sponsor's protocol ID
- AFT-32
- Status last verified
- Sep 2026
- First submitted
- 21 Mar 2018
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Herrmann A, Hoster E, Zwingers T, Brittinger G, Engelhard M, Meusers P, Reiser M, Forstpointner R, Metzner B, Peter N, Wormann B, Trumper L, Pfreundschuh M, Einsele H, Hiddemann W, Unterhalt M, Dreyling M. Improvement of overall survival in advanced stage mantle cell lymphoma. J Clin Oncol. 2009 Feb 1;27(4):511-8. doi: 10.1200/JCO.2008.16.8435. Epub 2008 Dec 15.
PubMed 19075279Medema RH, Herrera RE, Lam F, Weinberg RA. Growth suppression by p16ink4 requires functional retinoblastoma protein. Proc Natl Acad Sci U S A. 1995 Jul 3;92(14):6289-93. doi: 10.1073/pnas.92.14.6289.
PubMed 7603984Fry DW, Bedford DC, Harvey PH, Fritsch A, Keller PR, Wu Z, Dobrusin E, Leopold WR, Fattaey A, Garrett MD. Cell cycle and biochemical effects of PD 0183812. A potent inhibitor of the cyclin D-dependent kinases CDK4 and CDK6. J Biol Chem. 2001 May 18;276(20):16617-23. doi: 10.1074/jbc.M008867200. Epub 2001 Feb 6.
PubMed 11278443Marzec M, Kasprzycka M, Lai R, Gladden AB, Wlodarski P, Tomczak E, Nowell P, Deprimo SE, Sadis S, Eck S, Schuster SJ, Diehl JA, Wasik MA. Mantle cell lymphoma cells express predominantly cyclin D1a isoform and are highly sensitive to selective inhibition of CDK4 kinase activity. Blood. 2006 Sep 1;108(5):1744-50. doi: 10.1182/blood-2006-04-016634. Epub 2006 May 11.
PubMed 16690963Wang ML, Rule S, Martin P, Goy A, Auer R, Kahl BS, Jurczak W, Advani RH, Romaguera JE, Williams ME, Barrientos JC, Chmielowska E, Radford J, Stilgenbauer S, Dreyling M, Jedrzejczak WW, Johnson P, Spurgeon SE, Li L, Zhang L, Newberry K, Ou Z, Cheng N, Fang B, McGreivy J, Clow F, Buggy JJ, Chang BY, Beaupre DM, Kunkel LA, Blum KA. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2013 Aug 8;369(6):507-16. doi: 10.1056/NEJMoa1306220. Epub 2013 Jun 19.
PubMed 23782157Martin P, Bartlett NL, Blum KA, Park S, Maddocks K, Ruan J, Ridling L, Dittus C, Chen Z, Huang X, Inghirami G, DiLiberto M, Chen-Kiang S, Leonard JP. A phase 1 trial of ibrutinib plus palbociclib in previously treated mantle cell lymphoma. Blood. 2019 Mar 14;133(11):1201-1204. doi: 10.1182/blood-2018-11-886457. Epub 2019 Jan 28.
PubMed 30692121Chiron D, Di Liberto M, Martin P, Huang X, Sharman J, Blecua P, Mathew S, Vijay P, Eng K, Ali S, Johnson A, Chang B, Ely S, Elemento O, Mason CE, Leonard JP, Chen-Kiang S. Cell-cycle reprogramming for PI3K inhibition overrides a relapse-specific C481S BTK mutation revealed by longitudinal functional genomics in mantle cell lymphoma. Cancer Discov. 2014 Sep;4(9):1022-35. doi: 10.1158/2159-8290.CD-14-0098. Epub 2014 Jul 31.
PubMed 25082755Leonard JP, LaCasce AS, Smith MR, Noy A, Chirieac LR, Rodig SJ, Yu JQ, Vallabhajosula S, Schoder H, English P, Neuberg DS, Martin P, Millenson MM, Ely SA, Courtney R, Shaik N, Wilner KD, Randolph S, Van den Abbeele AD, Chen-Kiang SY, Yap JT, Shapiro GI. Selective CDK4/6 inhibition with tumor responses by PD0332991 in patients with mantle cell lymphoma. Blood. 2012 May 17;119(20):4597-607. doi: 10.1182/blood-2011-10-388298. Epub 2012 Mar 1.
PubMed 22383795
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Palbociclib (PD-0332991) in Combination With Ibrutinib in Patients With Previously Treated Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03478514
- Acronym / sponsor ID
- AFT-32
- Conditions
- Mantle Cell Lymphoma, B Cell Lymphoma
- Keywords
- mantle cell lymphoma, B-cell lymphoma, palbociclib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Alliance Foundation Trials, LLC.University, hospital or other
- Collaborators
- Pfizer
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 27 Mar 2018 (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.
The proposed study is a single-arm, multi-center, open-label phase II study of the combination of palbociclib and ibrutinib in patients with previously treated mantle cell lymphoma to evaluate the efficacy of this combination, with the primary objective of the study being to assess median PFS and the secondary objectives to include ORR, CR, DOR, OS and toxicity. Subjects will be enrolled and treated with palbociclib and ibrutinib with each cycle of therapy being 28 days. Treatment will be based on the recommended phase II dose (RP2D) from the phase I combination trial.
Detailed description
Treatment will consist of:
- Palbociclib administered at 100 mg oral once daily for 21 days on followed by 7 days off
- Ibrutinib administered at 560 mg oral continuously
Patients will continue to receive study drugs until disease progression, unacceptable toxicity, or withdrawal of consent. If at any time one of the agents is held due to toxicity, the other agent may be continued in those patients who are receiving clinical benefit.
Response will be assessed by PET/CT and/or CT every 3 cycles while on therapy for the first year and then every 6 cycles thereafter until disease progression or at the investigator's discretion if otherwise medically indicated. A PET will be required to confirm CR. A bone marrow biopsy will be performed in patients with bone marrow involvement at the start of therapy to confirm complete response once patients have otherwise met criteria for CR.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The proposed study is a single-arm, multi-center, open-label phase II study of the combination of palbociclib and ibrutinib in patients with previously treated mantle cell lymphoma.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: Palbociclib, Drug: IbrutinibAll patients will receive palbociclib at 100 mg oral once a day for 21 days, followed by 7 days off. Ibrutinib will be administered at 560 mg oral continuously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Subjects must have histologically or cytologically confirmed MCL as defined by the World Health Organization. All patients must have either t(11;14) by karyotype or fluorescent in-situ hybridization (FISH) or positive immunohistochemistry (IHC) for cyclin D1.
- Subjects must have measurable disease defined as at least one tumor lesion of at least 1.5 cm by CT or MRI, PET positive lesion(s) or a peripheral blood CD5+, CD19+ lymphocyte count of at least 5,000 cells/µL.
- Subjects must have received at least one prior systemic therapy.
- Subjects who have received prior autologous stem cell transplant are eligible. Patients that have undergone prior allogeneic stem cell transplant will only be eligible if the patient is no longer taking immunosuppressive therapy and there are no significant ongoing transplant-related adverse effects.
- Subjects must be age ≥ 18 years
Key exclusion criteria (14 listed)
- Subjects that have received prior CDK4/6 inhibitor will not be eligible.
- Subjects that have received any prior BTK inhibitor > 90 days prior to enrollment will not be eligible.
- Subjects with known or suspected CNS involvement.
- Concurrent therapy with other investigational products.
- History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib.
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 |
|---|---|---|
| PalbociclibAlso: Ibrance; PD-0332991Taken at 100 mg once daily for 21 days, followed by 7 days off | Drug | Single Arm |
| IbrutinibAlso: Imbruvica560 mg taken orally all patients throughout the study | Drug | Single Arm |
Primary outcome
Progression free survival
Time frame: 42 months
Time interval between registration and progression or death
5 secondary outcomes
Overall survival
Time frame: 42 months
Duration of response
Time frame: 42 months
Overall Response Rate
Time frame: 42 Months
Complete Response
Time frame: 42 Months
Toxicity: Incidence and severity of adverse events by summaries of toxicity data/contingency tables
Time frame: 42 Months
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 Oct 2026.
- Background: PubMed 19075279Herrmann A, Hoster E, Zwingers T, Brittinger G, Engelhard M, Meusers P, Reiser M, Forstpointner R, Metzner B, Peter N, Wormann B, Trumper L, Pfreundschuh M, Einsele H, Hiddemann W, Unterhalt M, Dreyling M. Improvement of overall survival in advanced stage mantle cell lymphoma. J Clin Oncol. 2009 Feb 1;27(4):511-8. doi: 10.1200/JCO.2008.16.8435. Epub 2008 Dec 15.
- Background: PubMed 7603984Medema RH, Herrera RE, Lam F, Weinberg RA. Growth suppression by p16ink4 requires functional retinoblastoma protein. Proc Natl Acad Sci U S A. 1995 Jul 3;92(14):6289-93. doi: 10.1073/pnas.92.14.6289.
- Background: PubMed 11278443Fry DW, Bedford DC, Harvey PH, Fritsch A, Keller PR, Wu Z, Dobrusin E, Leopold WR, Fattaey A, Garrett MD. Cell cycle and biochemical effects of PD 0183812. A potent inhibitor of the cyclin D-dependent kinases CDK4 and CDK6. J Biol Chem. 2001 May 18;276(20):16617-23. doi: 10.1074/jbc.M008867200. Epub 2001 Feb 6.
- Background: PubMed 16690963Marzec M, Kasprzycka M, Lai R, Gladden AB, Wlodarski P, Tomczak E, Nowell P, Deprimo SE, Sadis S, Eck S, Schuster SJ, Diehl JA, Wasik MA. Mantle cell lymphoma cells express predominantly cyclin D1a isoform and are highly sensitive to selective inhibition of CDK4 kinase activity. Blood. 2006 Sep 1;108(5):1744-50. doi: 10.1182/blood-2006-04-016634. Epub 2006 May 11.
- Background: PubMed 23782157Wang ML, Rule S, Martin P, Goy A, Auer R, Kahl BS, Jurczak W, Advani RH, Romaguera JE, Williams ME, Barrientos JC, Chmielowska E, Radford J, Stilgenbauer S, Dreyling M, Jedrzejczak WW, Johnson P, Spurgeon SE, Li L, Zhang L, Newberry K, Ou Z, Cheng N, Fang B, McGreivy J, Clow F, Buggy JJ, Chang BY, Beaupre DM, Kunkel LA, Blum KA. Targeting BTK with ibrutinib in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2013 Aug 8;369(6):507-16. doi: 10.1056/NEJMoa1306220. Epub 2013 Jun 19.
- Background: PubMed 30692121Martin P, Bartlett NL, Blum KA, Park S, Maddocks K, Ruan J, Ridling L, Dittus C, Chen Z, Huang X, Inghirami G, DiLiberto M, Chen-Kiang S, Leonard JP. A phase 1 trial of ibrutinib plus palbociclib in previously treated mantle cell lymphoma. Blood. 2019 Mar 14;133(11):1201-1204. doi: 10.1182/blood-2018-11-886457. Epub 2019 Jan 28.
- Background: PubMed 25082755Chiron D, Di Liberto M, Martin P, Huang X, Sharman J, Blecua P, Mathew S, Vijay P, Eng K, Ali S, Johnson A, Chang B, Ely S, Elemento O, Mason CE, Leonard JP, Chen-Kiang S. Cell-cycle reprogramming for PI3K inhibition overrides a relapse-specific C481S BTK mutation revealed by longitudinal functional genomics in mantle cell lymphoma. Cancer Discov. 2014 Sep;4(9):1022-35. doi: 10.1158/2159-8290.CD-14-0098. Epub 2014 Jul 31.
- Background: PubMed 22383795Leonard JP, LaCasce AS, Smith MR, Noy A, Chirieac LR, Rodig SJ, Yu JQ, Vallabhajosula S, Schoder H, English P, Neuberg DS, Martin P, Millenson MM, Ely SA, Courtney R, Shaik N, Wilner KD, Randolph S, Van den Abbeele AD, Chen-Kiang SY, Yap JT, Shapiro GI. Selective CDK4/6 inhibition with tumor responses by PD0332991 in patients with mantle cell lymphoma. Blood. 2012 May 17;119(20):4597-607. doi: 10.1182/blood-2011-10-388298. Epub 2012 Mar 1.
- Individual participant dataSharing planned: Undecided
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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.
Evanthia Galanis, MD principal investigator
Alliance Foundation Trials, LLC.
Kami Maddocks, MD study chair
Ohio State University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palbociclib and Ibrutinib in people with Mantle Cell Lymphoma and B Cell Lymphoma, run by Alliance Foundation Trials, LLC. at 9 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 31 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 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?
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?
Progression free survival (time frame: 42 months). 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 NCT03478514, which also lists 8 linked publications.
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 Oct 2026.