Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma - Full Text View

Purpose

This is a phase 1 trial designed to evaluate safety and tolerability of chemotherapy in combination with inotuzumab ozogamicin, an investigational product, in adults with CD22-positive non-Hodgkin's lymphoma. The trial will involve two arms. In one arm, subjects will receive chemotherapy regimen R-CVP (rituximab, cyclophosphamide, vincristine and prednisone). In the other arm, subjects will receive R-GDP (rituximab, gemcitabine, cisplatinum and dexamethasone). Subjects in both arms will also receive inotuzumab ozogamicin.

Condition	Intervention	Phase
Lymphoma, B-Cell	Drug: inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone Drug: inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Phase 1 Study Of R-CVP Or R-GDP In Combination With Inotuzumab Ozogamicin In Subjects With CD22-Positive Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma Steroids

Drug Information available for: Dexamethasone Cyclophosphamide Prednisone Dexamethasone acetate Vincristine sulfate Dexamethasone sodium phosphate Cisplatin Gemcitabine Gemcitabine hydrochloride Rituximab

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

To determine the tolerability, the initial safety profile, as evaluated by an analysis of laboratory results and adverse event (AE) reporting. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Determination of MTD or recommended dose of the immunochemotherapeutic regimens R-CVP or R-GDP given in combination with inotuzumab ozogamicin in subjects with CD22-positive NHL. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To obtain preliminary information on the antitumor activity of R-CVP or R-GDP in combination with inotuzumab ozogamicin as measured by ORR, progression-free survival, and overall survival data in MTD confirmation/expanded efficacy cohorts [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To evaluate PK of 0.8 mg/m2 of inotuzumab ozogamicin when combined with R CVP or with R-GDP [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
To develop a molecular predictor of response to inotuzumab ozogamicin plus R-CVP or R-GDP. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	March 2010
Estimated Study Completion Date:	February 2015
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 (R-CVP) Subjects in arm 1 will be enrolled in dose escalation cohorts that will initially evaluate an escalating dose of cyclophosphamide in combination with set doses of inotuzumab ozogamicin, vincristine, prednisone, and rituximab.	Drug: inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone Day 1: Rituximab at 375 mg/m2 Cyclophosphamide at 375 mg/m2 (cohort 1), 550mg/m2 (cohort 2), 750 mg/m2 (cohort 3, 4) Vincristine at 1.4 mg/m2 (max 2 mg) Day 2 Inotuzumab ozogamicin at 0.8 mg/m2 (cohort 1, 2, 3), 1.3 mg/m2 (cohort 4) Days 1-5: Prednisone at 40 mg/m2 Each cycle is 3 weeks, with a maximum of 6 cycles total. Other Name: CMC-544
Experimental: Arm 2 (R-GDP) Subjects in arm 2 will be enrolled in dose escalation cohorts that will initially evaluate escalating doses of gemcitabine and/or cisplatinum in combination with set doses of inotuzumab ozogamicin, dexamethasone, and rituximab.	Drug: inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone Day 1: Rituximab at 375 mg/m2 Gemcitabine at 500 mg/m2 (cohort 1, 2b, 3b), 1000mg/m2 (cohort 2a, 3a, 4, 5) Cisplatin at 37.5 mg/m2 (cohort 1, 2a), 50mg/m2 (cohort 2b, 3a), 75mg/m2 (cohort 3b, 4, 5) Day 2: Inotuzumab ozogamicin at 0.8 mg/m2 (cohort 1, 2a, 2b, 3a, 3b, 4), 1.3mg/m2 (cohort 5) Days 1-4: Dexamethasone at 40 mg Each cycle is 3 weeks, with a maximum of 6 cycles total. Other Name: CMC-544

Arms

Assigned Interventions

Experimental: Arm 1 (R-CVP)

Subjects in arm 1 will be enrolled in dose escalation cohorts that will initially evaluate an escalating dose of cyclophosphamide in combination with set doses of inotuzumab ozogamicin, vincristine, prednisone, and rituximab.

Drug: inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone

Day 1:

Rituximab at 375 mg/m2 Cyclophosphamide at 375 mg/m2 (cohort 1), 550mg/m2 (cohort 2), 750 mg/m2 (cohort 3, 4) Vincristine at 1.4 mg/m2 (max 2 mg)

Day 2 Inotuzumab ozogamicin at 0.8 mg/m2 (cohort 1, 2, 3), 1.3 mg/m2 (cohort 4)

Days 1-5:

Prednisone at 40 mg/m2

Each cycle is 3 weeks, with a maximum of 6 cycles total.

Other Name: CMC-544

Experimental: Arm 2 (R-GDP)

Subjects in arm 2 will be enrolled in dose escalation cohorts that will initially evaluate escalating doses of gemcitabine and/or cisplatinum in combination with set doses of inotuzumab ozogamicin, dexamethasone, and rituximab.

Drug: inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone

Day 1:

Rituximab at 375 mg/m2 Gemcitabine at 500 mg/m2 (cohort 1, 2b, 3b), 1000mg/m2 (cohort 2a, 3a, 4, 5) Cisplatin at 37.5 mg/m2 (cohort 1, 2a), 50mg/m2 (cohort 2b, 3a), 75mg/m2 (cohort 3b, 4, 5)

Day 2:

Inotuzumab ozogamicin at 0.8 mg/m2 (cohort 1, 2a, 2b, 3a, 3b, 4), 1.3mg/m2 (cohort 5)

Days 1-4:

Dexamethasone at 40 mg

Each cycle is 3 weeks, with a maximum of 6 cycles total.

Other Name: CMC-544

Eligibility

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

Criteria

Inclusion Criteria:

Dose escalation cohorts: subjects with diagnosis of CD22-positive Non-Hodgkin's Lymphoma (NHL) who have had at least 1 prior anticancer treatment, including prior treatment with rituximab and chemotherapy.
Expanded maximum tolerated dose (MTD) confirmation and preliminary efficacy cohorts: subjects with diagnosis of CD22-positive NHL who have had at least 1 prior anticancer treatment, including prior treatment with rituximab and chemotherapy or newly diagnosed subjects who are not candidates for anthracycline-based therapy.
At least 1 measurable disease lesion that is > 1 cm in the longest transverse diameter, with a product of the diameters > 2.25 cm2 by CT or magnetic resonance imaging (MRI).

Exclusion Criteria:

Candidate for potentially curative therapy such as stem cell transplantation.
Prior allogeneic hematopoietic stem cell transplantation (HSCT).
Prior autologous transplantation, radioimmunotherapy, or other anti CD22 immunotherapy <= 6 months before the first dose of investigational product.
More than 3 previous combination chemotherapy (2 or more cytotoxics) anticancer regimens.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055496

Contacts

Contact: Pfizer CT.gov Call Center	1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com

Show 28 Study Locations

Sponsors and Collaborators

Pfizer

UCB, Inc.

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01055496 History of Changes
Other Study ID Numbers:	3129K2-1105, B1931003
Study First Received:	January 21, 2010
Last Updated:	May 6, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Non-Hodgkin's lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Rituximab
Cisplatin
Cyclophosphamide
Dexamethasone
Prednisone

Vincristine
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013