CMC-R-GEMOX

LYSARC

Secteur Sainte Eugénie - pavillon 6D, Pierre Bénite, France, 69495

Elise Hutasse, LYSARC, +33 472669333, elise.hutasse@lysarc.org

Elise Hutasse, LYSARC, +33 472669333, elise.hutasse@lysarc.org

No

No

No

Final

22 Mar 2016

No

Yes

22 Mar 2016

Yes

The primary objective of the phase Ib part of the study is to determine the tolerability, safety and MTD or recommended dose of R-CMC544 alternating with RGEMOX in subjects aged from 18 to 80 years with CD20 and CD22 positive DLBCL in relapse after/refractory to 1st or 2nd line treatment, who are no candidates for autologous transplant. The primary objective of the phase II part of the study is to assess the efficacy or RCMC544 alternating with R-GEMOX as measured by the overall response rate (ORR) by IWG criteria (Cheson 1999) at the end of treatment (after complete treatment or at withdrawal).

Patients have been followed for safety (adverse event) during all study duration. If a patient does not respond to study treatment, relapses or has progressive disease, each site was free to initiate further treatment according to local guidelines

03 Dec 2012

No

Yes

France: 11

11

11

0

0

0

0

0

0

3

8

0

Induction

Not applicable

inotuzumab-ozogamicin

CMC544

Solution for injection/infusion

Intravenous use

CMC544 was given by IV route over 1 hour ± 10 minutes at the fixed dose rate of 50 mL/hour. Dose administered was 1.8mg/m²

Consolidation

Not applicable

inotuzumab-ozogamicin

CMC544

Solution for injection/infusion

Intravenous use

CMC544 was given by IV route over 1 hour ± 10 minutes at the fixed dose rate of 50 mL/hour. Dose administered was 1.8mg/m²

Induction

experimental

Experimental

Evaluable set

The evaluable population includes all enrolled patients who received at least one dose of any investigational drugs. Primary endpoint of the phase II will be analyzed on this population. Secondary efficacy and safety endpoints (for both phase Ib and II) will be performed on this population.

DLT evaluable set

The DLT evaluable population includes all patients from “Evaluable population” with a DLT assessment. It is considered that a patient have a DLT assessment if he/she performed completely the first two cycles unless a DLT occurred before the end of the cycle 2, in which case he/she remains evaluable for DLT. Primary endpoint of the phase Ib will be analyzed on this population

Recommended dose will be identified according to the incidence of DLTs during the first 2 cycles of treatment (induction). DLT is defined as follows (NCI CTCAE vs. 4): - Grade 4 neutropenia ≥ 7 days - Grade 4 thrombocytopenia ≥ 7 days - Grade 3 or 4 thrombocytopenia associated with bleeding requiring a transfusion - Grade 3 non-hematologic toxicity (except alopecia) ≥ 7 days or determined to be investigational product-related - Grade 4 non-hematologic toxicity (except alopecia) - Grade 4 AST/ALT increase irrespective of duration - Grade 2 hyperbilirubinemia (> 1.5 x ULN) > 7 days - Grade 3 or greater QTc prolongation (average of three ECGs) - Delayed recovery from an investigational product-related toxicity that prevents redosing by more than 21 days

Primary

Two first induction cycles

ORR as defined by Cheson 99 criteria: ORR = CR/CRu/PR

Secondary

At the end of treatment defined as after complete treatment or at permanent treatment discontinuation

Adverse Events (AE) occurring from the signing of the Informed Consent and until 30 days after the end of the last cycle of treatment have been recorded on the AE pages of the CRF.

Only grade 3 and 4 toxicities (NCIC Common Toxicity Criteria grading system – version 4.03) or grade 2 for infections, and toxicities (grade 1 to 4) related to a Serious Adverse Event as described below, have been be reported as “Adverse Event” in the appropriate CRF pages. All “Alopecia” toxicity have not been recorded as “Adverse Event”.

4.03

All patients