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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Gainesville, Florida, 32608 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
B-Cell Lymphoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

- More than 3 previous combination chemotherapy (2 or more cytotoxics) anticancer
regimens.

NCT01055496
Pfizer
Completed
Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma

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Study Evaluating Chemotherapy in Combination With Inotuzumab Ozogamicin In Subjects With Non-Hodgkin's Lymphoma
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma, B-Cell
  • 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
  • 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
  • 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.
    Intervention: Drug: inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone
  • 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.
    Intervention: Drug: inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone
Ogura M, Tobinai K, Hatake K, Davies A, Crump M, Ananthakrishnan R, Ishibashi T, Paccagnella ML, Boni J, Vandendries E, MacDonald D. Phase I Study of Inotuzumab Ozogamicin Combined with R-CVP for Relapsed/Refractory CD22+ B-cell Non-Hodgkin Lymphoma. Clin Cancer Res. 2016 Oct 1;22(19):4807-4816. Epub 2016 May 6.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
March 2014
July 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Hong Kong,   Japan,   Korea, Republic of,   Singapore,   United Kingdom,   United States
 
 
NCT01055496
3129K2-1105
B1931003
No
Not Provided
Not Provided
Pfizer
Pfizer
UCB Pharma
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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