TerminatedPhase 1/2

Flavopiridol in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma

Stopped: Administratively Complete

United States46 participantsStarted 2005-12

Plain-language summary

This phase I/II trial is studying the side effects and best dose of flavopiridol and to see how well it works in treating patients with lymphoma or multiple myeloma. Drugs used in chemotherapy, such as flavopiridol, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of 1 of the following hematologic malignancies: * Hodgkin's lymphoma * Non-Hodgkin's lymphoma (NHL) * Multiple myeloma * Patients in the phase II portion of the study are enrolled in 1 of the following strata according to diagnosis\* * Stratum 1: Indolent B-cell NHL (non-Hodgkin's lymphoma), follicle center B-cell NHL (grade 1, 2, or 3), marginal zone lymphoma, Waldenstrom's macroglobulinemia, or small lymphocytic lymphoma (without blood lymphocytosis at any point in the disease process) * Must have progressive lymphadenopathy, worsening cytopenias, or progressive symptoms attributed to lymphoma * Must require therapy, as determined by progressive anemia, thrombocytopenia, symptoms (e.g., fever, night sweats, weight loss, or fatigue), or progressive lymphadenopathy that causes discomfort * Received ≥ 2 prior therapies, including rituximab * Stratum 1a: Hairy cell leukemia * Must require therapy, as determined by progressive cytopenias or symptoms (fever, night sweats, weight loss, or fatigue) * Must have received ≥ 2 therapies * Stratum 2: Mantle cell lymphoma, as determined by the presence of cyclin D1 staining OR t(11;14) * Stratum 3: Intermediate grade B-cell NHL, including diffuse large B-cell NHL and T-cell rich B-cell NHL * Diffuse large B-cell NHL arising from an indolent NHL (i.e., transformed lymphoma) allowed * Ineligible for potentially curative autologous stem cell transplantation * …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I)

Timeframe: 28 days

Maximum Tolerated Dose (MTD)

Timeframe: 28 days

Complete and Partial Response Rate (Phase II)

Timeframe: Up to 2 years

Qualitative and Quantitative Toxicities in Regard to Organ Specificity

Timeframe: Up to 30 days after completion of study treatment

Lymphoid/Plasma Cell Malignancies

Timeframe: Up to 2 years

Trial details

NCT IDNCT00112723

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2011-02

Results submitted2015-03-23

View on ClinicalTrials.gov More Adult Lymphocyte Depletion Hodgkin Lymphoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Disease-specific Dose-limiting Toxicity and Maximum Tolerated Dose of Flavopiridol Graded According to the CTCAE (Common Toxicity Criteria for Adverse Effects) Version 4.0 (Phase I)

Timeframe: 28 days

Maximum Tolerated Dose (MTD)

Timeframe: 28 days

Complete and Partial Response Rate (Phase II)

Timeframe: Up to 2 years

Qualitative and Quantitative Toxicities in Regard to Organ Specificity

Timeframe: Up to 30 days after completion of study treatment

Lymphoid/Plasma Cell Malignancies

Timeframe: Up to 2 years