A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.

NCT00472420 | Completed Phase 2 Results

• 1 other identifier: ML20493
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 7

Brief Summary

This single arm study will evaluate the benefit of adding MabThera to standard induction chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and tolerability of a MabThera-containing first line regimen will also be assessed. All patients will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Conditions

Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Complete Remission (CR) (Including Unconfirmed CR [CR(u)]) or Partial Remission (PR)

  CR was defined by: a) disappearance of clinical/radiographic evidence of disease, disease-related symptoms, and biochemical abnormalities; b) decrease in lymph nodes (LNs) greater than (\>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) to less than (\<) 1.5 cm, a decrease in LNs 1.1 - 1.5 cm to 1 cm or 75 percent (%) decrease in sum of the products of GTD (SPD); c) non-palpable spleen, decreased size of enlarged organs, and disappearance of nodules; and d) disappearance of bone marrow (BM) infiltrate. CR(u) was defined as fulfilling a) and c), above, with greater than or equal to (≥) 1 of the following: a) \> 75% decrease in SPD of LNs \> 1.5 cm, and \> 75% decrease in SPD of previously confluent LNs; b) indeterminate BM, or c) confirmed CR. PR was defined by: a) 50% decrease in SPD of the 6 largest LNs; b) no increase in LNs, liver, or spleen size; c) ≥ 50% decrease in splenic and hepatic nodule SPDs; d) no measurable disease in other organs; and e) no new sites of disease.

  Screening, Baseline (BL), every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)

Secondary Outcomes (2)

• Progression Free Survival (PFS)

  Screening, BL, every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)

• Event Free Survival (EFS)

  Screening, BL, every 21 days thereafter up to Week 27, every 3 months thereafter up to Month 24, Withdrawal Visit (4 weeks after discontinuation of study treatment)

Study Arms (1)

1

EXPERIMENTAL

Drug: rituximab [MabThera/Rituxan]; Drug: First line chemotherapy

Interventions

rituximab [MabThera/Rituxan] DRUG

375mg/m2 iv every 3 weeks

1

First line chemotherapy DRUG

As prescribed

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically-proven mantle cell lymphoma;
• previously untreated disease at stage II, III and IV, requiring therapy.

You may not qualify if:

• known hypersensitivity reaction to rituximab, or known anti-murine antibody reactivity or known hypersensitivity to murine antibodies;
• active malignancy other than mantle cell lymphoma within 5 years of start of study, with the exception of resected basal cell cancer, squamous cell cancer of the skin, or in situ cancer of the cervix;
• serious disorders interfering with full standard dosing chemotherapy;
• stage I disease.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (7)

National Institute of Oncology, A Dept of Internal Medicine

Budapest, 1122, Hungary

Location

University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology

Debrecen, 4032, Hungary

Location

Petz Aladar Megyei Korhaz; Hematologia

Győr, 9024, Hungary

Location

Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology

Kaposvár, 7400, Hungary

Location

Miskolci Semmelweis Korhaz; Ii Belgyogyaszat

Miskolc, 3529, Hungary

Location

University of Szeged, II Dept of Internal Medicine

Szeged, 6720, Hungary

Location

Zala Megyei Korhaz; Ii. Belgyogyaszat

Zalaegerszeg, 8901, Hungary

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 11, 2007
• Study Start: June 27, 2007
• Primary Completion: May 25, 2011
• Study Completion: May 25, 2011
• Last Updated: August 15, 2017
• Results First Posted: November 26, 2014

Record last verified: 2017-06

Locations

HU (7)