Clinical trial · Interventional
Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma
NCT00005074CI-TRIAL-00044586completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have previously untreated or relapsed mantle cell lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alvocidib | Drug | Alvocidib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed mantle cell lymphoma (at initial diagnosis) nonrefractory to prior therapy or with no prior therapy
* No documented disease progression while receiving prior chemotherapy
* CD20 and CD5 positive
* Presence of clinically and/or radiologically documented disease
* At least 1 site of disease must be bidimensionally measurable
* Bone lesions not considered bidimensionally measurable
* Minimum indicator lesions must be:
* Lymph nodes at least 1.5 cm x 1.5 cm by physical exam or spiral CT scan OR
* Other nonnodal lesions at least 1 cm x 1 cm by MRI, CT scan, or physical exam
* No known CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm3
* Platelet count at least 75,000/mm3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit or normal (ULN)
* AST no greater than 2.5 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN OR
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No clinically significant cardiac symptomatology
* If history of cardiac disease, cardiac ejection fraction greater than 50%
Pulmonary:
* No clinically significant pulmonary symptomatology
* If history of symptomatic pulmonary disease:
* FEV1, FVC, and TLC greater than 60% predicted
* DLCO greater than 50% predicted
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Must be accessible for treatment and follow-up (i.e., no geographical limitations)
* No uncontrolled bacterial, fungal, or viral infection
* No other serious concurrent disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior radioactive monoclonal antibody therapy
* Prior rituximab allowed
Chemotherapy:
* See Disease Characteristics
* No more than 2 prior chemotherapy regimens allowed
* Same chemotherapy combination given for first line and second line therapy considered 2 regimens
* At least 6 weeks since prior chemotherapy
* No prior high-dose chemotherapy and stem cell transplantation
* No other concurrent cytotoxic chemotherapy
Endocrine therapy:
* No concurrent corticosteroids
Radiotherapy:
* No prior radiotherapy to greater than 25% of functioning bone marrow
* At least 4 weeks since prior radiotherapy (except low-dose, non-myelosuppressive radiotherapy) and recovered
* No concurrent radiotherapy to sole site of measurable disease
Surgery:
* At least 2 weeks since prior major surgery
Other:
* No other concurrent investigational anticancer agentsReferences
Publications (1)
- RESULTKouroukis CT, Belch A, Crump M, Eisenhauer E, Gascoyne RD, Meyer R, Lohmann R, Lopez P, Powers J, Turner R, Connors JM; National Cancer Institute of Canada Clinical Trials Group. Flavopiridol in untreated or relapsed mantle-cell lymphoma: results of a phase II study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2003 May 1;21(9):1740-5. doi: 10.1200/JCO.2003.09.057. PMID 12735303