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Early treatment intensification in patients with high risk Mantle Cell Lymphoma using CAR-T-cell treatment after an abbreviated induction therapy with Rituximab and Ibrutinib and 6 months Ibrutinib maintenance (Arm A) as compared to standard of care induction and maintenance (Arm B)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502405-15-01
Acronym
CARMAN
Enrollment
150
Registered
2024-08-12
Start date
2024-04-08
Completion date
Unknown
Last updated
2026-01-22

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

Conditions

Mantle Cell Lymphoma (MCL)

Brief summary

Primary endpoint: Failure-free survival (FFS) from randomization. Failure events are defined as the earliest of the following: o Stable disease at the end of induction (Arm B, or Arm A if CAR-T-cells are not infused) or within 12 weeks from CAR-T-cell infusion (Arm A), o Progressive disease at or at any time after end of induction treatment, and o Death from any cause at any time

Detailed description

Progression-free survival (PFS) from randomization, Complete remission (CR) rate and overall response rate (ORR: CR, PR) approx. 6.5 months from randomization, Rate of PET negative CR (complete metabolic response rate, per Lugano criteria) approx. 6.5 months from randomization, PFS in responders approx. 6.5 months from randomization (landmark analysis), Best response within 2 years from randomization, Time to best response and time to first response from randomization, Overall survival (OS) from randomization, Safety: adverse events, serious adverse events, graded according to CTCAE

Interventions

DRUGVINCRISTINE SULFATE
DRUGCYCLOPHOSPHAMIDE
DRUGFLUDARABINE
DRUGBENDAMUSTINE
DRUGPEGFILGRASTIM
DRUGCISPLATIN
DRUGDOXORUBICIN
DRUGDEXAMETHASONE
DRUGRITUXIMAB
DRUGTOCILIZUMAB
DRUGMELPHALAN
DRUGPREDNISOLONE
DRUGOXALIPLATIN
DRUGCYTARABINE
DRUGCARMUSTINE
DRUGTHIOTEPA
DRUGETOPOSIDE
DRUGFILGRASTIM

Sponsors

Klinikum Der Universitat Munchen AöR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Primary endpoint: Failure-free survival (FFS) from randomization. Failure events are defined as the earliest of the following: o Stable disease at the end of induction (Arm B, or Arm A if CAR-T-cells are not infused) or within 12 weeks from CAR-T-cell infusion (Arm A), o Progressive disease at or at any time after end of induction treatment, and o Death from any cause at any time

Secondary

MeasureTime frame
Progression-free survival (PFS) from randomization, Complete remission (CR) rate and overall response rate (ORR: CR, PR) approx. 6.5 months from randomization, Rate of PET negative CR (complete metabolic response rate, per Lugano criteria) approx. 6.5 months from randomization, PFS in responders approx. 6.5 months from randomization (landmark analysis), Best response within 2 years from randomization, Time to best response and time to first response from randomization, Overall survival (OS) from randomization, Safety: adverse events, serious adverse events, graded according to CTCAE

Countries

Czechia, France, Germany, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026