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Completed

NCT Number: NCT00117598

Study Evaluating Temsirolimus (CCI-779) In Mantle Cell Lymphoma (MCL)

This is an open-label, randomized trial in relapsed refractory subjects with mantle cell lymphoma (MCL).

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mantle cell lymphoma (MCL) confirmed with histology, immunophenotype, and cyclin D1 analysis
  • Received 2 to 7 prior therapies which may include hematopoietic stem cell transplant (i.e. induction + consolidation + maintenance)
  • Prior treatment with an alkylating agent and an anthracycline, rituximab, individually or in combination, and status that is at least one of the following:
  • Primary disease refractory to at least 2 regimens;
  • Refractory to at least 1 regimen after first relapse;
  • Refractory or untreated after second or greater relapse;
  • Refractory to first line and relapsed after second line. Chemotherapy combinations may include, but are not limited to: CHOP (Cyclophosphamide, doxorubicin, vincristine, prednisone), R-CHOP (Rituximab, Cyclophosphamide, doxorubicin, vincristine, prednisone), FCM (Fludarabine, cyclophosphamide, mitoxantrone), R-FCM (Rituximab,Fludarabine, cyclophosphamide, mitoxantrone), ICE(Ifosfamide, carboplatin, etoposide), DHAP (Dexamethasone, cisplatin, cytarabine) and hyper-CVAD (Cyclophosphamide, doxorubicin, vincristine, dexamethasone).

Exclusion criteria

  • Subjects who are less than or equal to six month from allogeneic hematopoietic stem cell transplant and who are on immunosuppressive therapy or have evidence of graft versus host disease
  • Prior investigational therapy within 3 weeks of first dose. Investigational therapy is defined as treatment that is not approved for any indication.
  • Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth. (Treated CNS metastases must be stable for > 2 weeks prior to Day 1.)

Treatment and study plan

Temsirolimus (CCI-779)

Drug

Temsirolimus 175 mg IV once a week for 3 weeks; followed by 75 mg IV once a week

Investigator's choice

Drug

Any of the following single agent treatments:

  • Fludarabine 25 mg/m2 IV over 30 minutes daily for 5 consecutive days, every 28 days or oral administration, as appropriate.
  • Chlorambucil 0.1 (0.1-0.2) mg/kg PO daily for 3 to 6 weeks as required OR 0.4 (0.3 0.8) mg/kg PO every 21 to 28 days
  • Gemcitabine 1 gm/m2 IV over 30 minutes on days 1, 8 and 15 every 28 days or day 1 and day 8 every 21 days
  • Cyclophosphamide 300 (200-450) mg/m2 PO daily for 5 consecutive days every 21 to 28 days, OR 600 (400-1200) mg/m2 IV every 21 to 28 days
  • Cladribine 5 mg/m2 IV daily for 5 consecutive days, every 28 days for 2-6 cycles depending on response,
  • Etoposide 50 (50-150) mg/m2 IV daily for 3-5 days every 21 to 28 days OR 100 (50 300) mg/m2 PO daily for 3-5 days every 21 to 28 days
  • Prednisone 40 (20-60) mg/m2 PO daily or every other day
  • Dexamethasone 20(20-40) mg PO/IV daily for 5 consecutive days, every 14 - 28 day

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

    The period from randomization until disease progression, death or date of last contact.

Secondary outcomes

  1. Percentage of Participants With Objective Response

    Time frame: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

    Assessment of complete or partial response (CR, PR) or uncomplete response (CRu) using Response Evaluation Criteria in Solid Tumors. CR: 1) No disease evident. 2) Lymph node, nodal mass regressed to normal size. 3) Previously enlarged organ ↓ size. 4) Bone marrow clear on repeat aspirate, biopsy. CRu: CR 1 and 3, at least 1 of following: Lymph node regressed >75%. Bone marrow ↑ number or aggregate size, no cytologic/architectural atypia. PR: ≥50% ↓ index lesion, no size ↑ in other nodes, liver, spleen. Splenic and hepatic nodule regressed ≥50%. No new disease.

Other outcomes

  1. Overall Survival (OS)

    Time frame: Baseline up to 5 years

    Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.

  2. Time to Response

    Time frame: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

    Time between the date of randomization and the first date of objective response for participants with a confirmed objective response.

  3. Duration of Response

    Time frame: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

    Time from the first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented; censored at last valid tumor assessment.

  4. Time to Failure (TTF)

    Time frame: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

    TTF is defined as the time from randomization to the date of the first documentation of Progressive Disease (PD), the date of treatment discontinuation except completion of treatment, or date of death (any cause).

  5. Time to Tumor Progression (TTP)

    Time frame: Baseline, every 8 weeks up to Year 1, then every 12 weeks up to Year 2, and then every 6 months until tumor progression or death (up to Year 5)

    TTP: time from randomization to first documentation of objective tumor progression (including recurrence); censored at last valid tumor assessment.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Open-Label, Randomized, Phase 3 Trial Of Intravenous Temsirolimus (CCI-779) At Two Dose Levels Compared To Investigator's Choice Therapy In Relapsed, Refractory Subjects With Mantle Cell Lymphoma (MCL)

Acronym: OPTIMAL

Important dates

Study start
2005
Primary completion
2007
Study completion
2011
First posted
Jul 7, 2005
Registry last updated
Mar 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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