A Trial in Patients With Diffuse Large-B-cell Lymphoma Comparing Pixantrone Against Doxorubicin (RAPID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CTI BioPharma
ClinicalTrials.gov Identifier:
NCT00268853
First received: December 21, 2005
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to compare the standard CHOP-R regimen of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Rituximab to CPOP-R (same regimen, but substituting Doxorubicin with Pixantrone). The objective is to show that CPOP-R is not inferior to CHOP-R.


Condition Intervention Phase
Diffuse Large-Cell Lymphoma
Drug: CPOP-R
Drug: CHOP-R
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cyclophosphamide, Doxorubicin, Vincristine, Prednisone Plus Rituximab (CHOP-R) and Cyclophosphamide, Pixantrone, Vincristine, Prednisone Plus Rituximab (CPOP-R) in Patients With Diffuse Large-B-cell Lymphoma: A Phase II, Randomized, Multicenter, Comparative Trial

Resource links provided by NLM:


Further study details as provided by CTI BioPharma:

Primary Outcome Measures:
  • The primary objective is to show that the response rate for CPOP-R is not inferior to that of CHOP-R. [ Time Frame: Subjects followed for 5 years post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objective is to compare the overall survival, event free survival and cardiac safety of the 2 treatments. Other comparisons will include duration of response, overall objective response rate, and time to treatment failure (TTF). [ Time Frame: Subjects followed for 5 years post treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 280
Study Start Date: November 2005
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: CPOP-R
Cyclophosphamide 750 mg/m2, pixantrone 150 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles
Active Comparator: 2 Drug: CHOP-R
Cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, vincristine 1.4 mg/m2, rituximab 375 mg.m2 on Day 1 of a 21 day cycle, for 8 cycles Prednisone 100 mg/day on Day 1-5 of a 21 day cycle for 8 cycles

Detailed Description:

In preclinical studies, pixantrone has shown significantly less cardiotoxicity than other anthracyclines or anthracenediones. In addition, patients with relapsed disease, who have received prior maximum doses of anthracyclines, have tolerated high doses of pixantrone with minimal added cardiotoxicity. Pixantrone is currently being studied in a Phase III study in 3rd line aggressive NHL.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previously untreated and histologically confirmed diffuse large B-cell lymphoma according to REAL/WHO classification.
  2. Stage II, III or IV disease
  3. CD20+
  4. Age ≥ 18 years
  5. ECOG performance status ≤ 2
  6. At least one objectively bidimensionally measurable lesion as demonstrated by CT, spiral CT, or MRI that can be followed for response as target lesion. Patients with the following sites of disease are NOT eligible:

    • Patients with only skin lesions or only palpable lymph nodes.
    • Patients with spleen or bone marrow as only site of disease.
  7. Life expectancy ≥ 3 months
  8. Serum bilirubin ≤ 1.5 x the institution's upper limit normal (ULN) and creatinine ≤ 2.0 ULN and AST or ALT ≤ 2.0 x the institution's ULN. If hepatic involvement by lymphoma is present, AST or ALT may be ≤ 5.0 x the institution's ULN.
  9. LVEF ≥ 50% determined by MUGA scan.
  10. Ability to comply with the visit schedule and assessments required by the protocol.
  11. Signed approved informed consent, with understanding of study procedures.

Exclusion Criteria:

  1. Any prior chemotherapy (except intrathecal chemotherapy at diagnosis and pretreatment corticosteroid therapy) or radiotherapy: Patients may receive corticosteroid pretreatment therapy for up to 7 days after randomization, pending Investigator's decision to reduce tumor burden.
  2. Histological diagnosis of T-cell lymphoma or any B-cell lymphoma other than diffuse large B-cell.
  3. History of indolent lymphoma
  4. Active CNS involvement based on clinical evaluation .
  5. HIV-related lymphoma.
  6. Major thoracic and/or abdominal surgery within the 4 weeks before randomization from which the patient has not fully recovered except for diagnosis of NHL. Patients who have had minor surgery may be enrolled after a ≥ 1 week recovery period except for diagnosis of NHL.
  7. Clinically significant cardiovascular abnormalities
  8. Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization or deep seated or systemic mycotic infections.
  9. Clinical symptoms suggesting unresolved HIV, HBV or HCV infection. Patients with seropositivity presumed to be due to prior vaccination against Hepatitis B virus or resolved infection will not be excluded.
  10. Active or history of another malignancy except cured basal cell carcinoma of skin or carcinoma in situ of uterine cervix. Patients who have been in remission from another previous malignancy for >5 years will be considered eligible.
  11. Known hypersensitivity to the excipients or the study drugs that the patient will receive.
  12. Any contraindications to the study drugs as described in the Summary of Product Characteristics or package inserts. 13. Neurological contraindication to vincristine (e.g. peripheral neuropathy).

14. Any condition which, in the judgment of the Investigator, would place the subject at undue risk, interfere with the results of the study, or make the subject otherwise unsuitable. 15. General status that, in the opinion of the Investigator does not permit the administration of eight courses of CHOP-R/CPOP-R. 16. Treatment with any other investigational study drug within 30 days before randomization. Patient must have recovered from all side effects of other investigational therapy. 17. Potentially fertile men and women and their sexual partners not willing to use adequate contraception as defined by the Investigator during the study and for 6 months after the last day of study drug administration.

18. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268853

  Show 75 Study Locations
Sponsors and Collaborators
CTI BioPharma
Investigators
Study Director: Gabor Jurida, M.D. CTI BioPharma
  More Information

No publications provided

Responsible Party: CTI BioPharma
ClinicalTrials.gov Identifier: NCT00268853     History of Changes
Other Study ID Numbers: PIX203
Study First Received: December 21, 2005
Last Updated: July 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by CTI BioPharma:
lymphoma
NHL
large cell
phase II
CHOP R
CPOP R
non Hodgkins

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Pixantrone
Prednisone
Vincristine
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors

ClinicalTrials.gov processed this record on October 30, 2014