MABTENANCE: International, Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment versus Observation alone in Patients with Chronic Lymphocytic Leukemia

MABTENANCE: International, Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment versus Observation alone in Patients with Chronic Lymphocytic Leukemia - Mabtenance

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013651-29-AT

Enrollment

256

Registered

2009-12-11

Start date

2010-01-13

Completion date

Unknown

Last updated

2018-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia MedDRA version: 19.0 Level: LLT Classification code 10009310 Term: CLL System Organ Class: 100000004864

Interventions

Trade Name: MabThera 100 mg Product Name: Rituximab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Other descriptive name: MabThera®

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •B-CLL •Age =18 •Previous Rituximab containing induction treatment of the CLL in 1st or 2nd line •Patient must be in complete remission or partial remission after an induction treatment containing rituximab •ANC (absolute neutrophil count) = 1.0 x 109/L •Patient using a reliable means of contraception for the duration of the treatment including 2 months thereafter Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 256 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 256

Exclusion criteria

Exclusion criteria: •Active uncontrolled bacterial, viral or fungal infection •Positivity for HIV, Hepatitis B or C •Significantly reduced organ functions and bone marrow dysfunction not due to CLL •creatinine clearance of below 30 ml/min •Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina •Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter's syndrome, or prolymphocytic leukemia (PLL))

Design outcomes

Primary

Measure	Time frame
Main Objective: Progression-free survival: Clinical PFS is defined as the period from randomization until disease progression or death due to the underlying disease. ;Secondary Objective: •MRD-progression free survival •PFS and MRD PFS in relation to gender •conversion rate to MRD negative •median MRD levels •conversion rate to CR •effect of MRD levels on clinical PFS and OS •Event free survival •Time to next treatment •overall survival •safety •benefit according to cytogenetic risk group (trisomy 12, del 11q, del 17p and del 13q ), IgVH mutation status, ZAP 70 and CD38 expression ;Primary end point(s): Progression free survival;Timepoint(s) of evaluation of this end point: This randomized Phase III trial aims to investigate the impact of Rituximab maintenance therapy vs. observation on the progression free survival of patients with first line or relapsed CLL.	—

Measure

Time frame

Main Objective: Progression-free survival: Clinical PFS is defined as the period from randomization until disease progression or death due to the underlying disease. ;Secondary Objective: •MRD-progression free survival •PFS and MRD PFS in relation to gender •conversion rate to MRD negative •median MRD levels •conversion rate to CR •effect of MRD levels on clinical PFS and OS •Event free survival •Time to next treatment •overall survival •safety •benefit according to cytogenetic risk group (trisomy 12, del 11q, del 17p and del 13q ), IgVH mutation status, ZAP 70 and CD38 expression ;Primary end point(s): Progression free survival;Timepoint(s) of evaluation of this end point: This randomized Phase III trial aims to investigate the impact of Rituximab maintenance therapy vs. observation on the progression free survival of patients with first line or relapsed CLL.

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Secondary

Measure	Time frame
Secondary end point(s): - MRD-progression free survival - PFS and MRD PFS in relation to gender - conversion rate to MRD negative - median MRD levels - conversion rate to CR - effect of MRD levels on clinical PFS and OS - Event free survival - Time to next treatment - overall survival - safety - benefit according to cytogenetic risk group (trisomy 12, del 11q, del 17p and del 13q ), IgVH mutation status, ZAP 70 and CD38 expression;Timepoint(s) of evaluation of this end point: 4 years enrolment 2 years treatment 2 years Follow up	—

Measure

Time frame

Secondary end point(s): - MRD-progression free survival - PFS and MRD PFS in relation to gender - conversion rate to MRD negative - median MRD levels - conversion rate to CR - effect of MRD levels on clinical PFS and OS - Event free survival - Time to next treatment - overall survival - safety - benefit according to cytogenetic risk group (trisomy 12, del 11q, del 17p and del 13q ), IgVH mutation status, ZAP 70 and CD38 expression;Timepoint(s) of evaluation of this end point: 4 years enrolment 2 years treatment 2 years Follow up

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Countries

Austria, Bulgaria, Czech Republic, Slovakia

Contacts

Public ContactDaniela Wolkersdorfer

AGMT

d.wolkersdorfer@agmt.at+436641422504

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026