3-year Progression-free Survival (PFS)
Primary
· 3 years
acceptable 3-yr PFS as 75% or higher, and unacceptable rate as 60% or lower.
| Group | Value | 95% CI |
|---|---|---|
| Chemotherapy | 63 | 50 – 78 |
Last reviewed · How we verify
NCT02633137
Sequential Chemotherapy and Lenalidomide Followed by Rituximab and Lenalidomide Maintenance for Untreated Mantle Cell Lymphoma
Completed
Phase 2
Results posted
Last updated 30 August 2024
What this trial tests
Phase 2 trial testing Lenalidomide in Mantle Cell Lymphoma in 49 participants. Completed in 7 November 2023.
Timeline
14 December 2015
Primary endpoint
7 November 2023
7 November 2023
7 November 2023
Quick facts
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 14 December 2015 |
| Primary completion | 7 November 2023 |
| Estimated completion | 7 November 2023 |
| Sites | 7 locations across United States |
Drugs / interventions tested
- Lenalidomide — full drug profile →
- R-CHOP — full drug profile →
- high-dose cytarabine (HIDAC) — full drug profile →
Conditions studied
- Mantle Cell Lymphoma — all drugs for Mantle Cell Lymphoma →
- Untreated — all drugs for Untreated →
Sponsor
Memorial Sloan Kettering Cancer Center — full company profile →
Who can join
18 and older, any sex, with Mantle Cell Lymphoma or Untreated. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Chemotherapy
Serious: 27/49 (55%)
Deaths: 18/49
Serious adverse events (32 terms)
| Reaction | System | Chemotherapy |
|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Platelet count decreased | Investigations | — |
| Lung infection | Infections and infestations | — |
| Anemia | Blood and lymphatic system disorders | — |
| Neutrophil count decreased | Investigations | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Fever | General disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Other cardiac disorder | Cardiac disorders | — |
| Cholecystitis | Hepatobiliary disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Creatinine increased | Investigations | — |
| Diarrhea | Gastrointestinal disorders | — |
| Edema limbs | General disorders | — |
| Enterocolitis infectious | Infections and infestations | — |
| Fatigue | General disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Other infections and infestations | Infections and infestations | — |
| Joint effusion | Musculoskeletal and connective tissue disorders | — |
| Palpitations | Cardiac disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
| Productive cough | Respiratory, thoracic and mediastinal disorders | — |
Other adverse events (47 terms — click to expand)
| Reaction | System | Chemotherapy |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Neutrophil count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Platelet count decreased | Investigations | — |
| Lymphocyte count decreased | Investigations | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Fatigue | General disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Alkaline phosphatase increased | Investigations | — |
| Hyperkalemia | Metabolism and nutrition disorders | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Blood bilirubin increased | Investigations | — |
| Constipation | Gastrointestinal disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Anxiety | Psychiatric disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Creatinine increased | Investigations | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Hypoglycemia | Metabolism and nutrition disorders | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Edema limbs | General disorders | — |
| Other general disorders and administration site conditions | General disorders | — |
| Hypernatremia | Metabolism and nutrition disorders | — |
| Weight loss | Investigations | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Depression | Psychiatric disorders | — |
| Dizziness | Nervous system disorders | — |
| Hypertension | Vascular disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Urinary frequency | Renal and urinary disorders | — |
Most-reported serious reactions: Febrile neutropenia, Platelet count decreased, Lung infection, Anemia, Neutrophil count decreased, Abdominal pain, Atrial fibrillation, Fever.
Data from ClinicalTrials.gov NCT02633137 adverse events section.
Sponsor's own description
The purpose of this study is to find out what effects, good and/or bad, the treatment including 1) Lenalidomide-RCHOP, 2) R-HIDAC, and 3) Lenalidomide-Rituximab maintenance has on the participant and their lymphoma.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Emerging therapies in mantle cell lymphoma.
Hanel W, Epperla N. · · 2020 · cited 33× · PMID 32552760 · DOI 10.1186/s13045-020-00914-1 -
Current trials for frontline therapy of mantle cell lymphoma.
Steiner RE, Romaguera J, Wang M. · · 2018 · cited 13× · PMID 29374487 · DOI 10.1186/s13045-018-0556-x -
Immunochemotherapy plus lenalidomide for high-risk mantle cell lymphoma with measurable residual disease evaluation.
Epstein-Peterson ZD, Drill E, Aypar U, Batlevi CL, et al · · 2024 · cited 3× · PMID 37646671 · DOI 10.3324/haematol.2023.282898
Verify or expand the search:
- PubMed search for NCT02633137
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02633137 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
- Last refreshed: 30 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02633137.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing