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

Primary Purpose

Lymphoma, B-Cell

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone

inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone

About this trial

This is an interventional treatment trial for Lymphoma, B-Cell focused on measuring Non-Hodgkin's lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Davis Cancer Pavillion and Shands Medical Plaza
Shands Cancer Hospital At The University Of Florida
Shands Hospital at the University of Florida
Fox Chase Cancer Center
The University of Texas MD Anderson Cancer Center
Northwest Medical Specialties, PLLC
Northwest Medical Specialties, PLLC
Northwest Medical Specialties, PLLC
Rainier Physicians, PC
Northwest Medical Specialties PLLC
UZ Gent
UZ Gasthuisberg
Cross Cancer Institute
Queen Elizabeth Health Sciences Centre
Princess Margaret Cancer Centre
Hospital Saint-Louis - Service d'Hemato-Oncologie
Hopital Saint-Louis -Universite Paris VII
Centre Hospitalier Lyon Sud - Service d'Hematologie
Prince of Wales Hospital
Nagoya Daini Red Cross Hospital
National Cancer Center Hospital
Cancer Institute Hospital, Japanese Foundation For Cancer Research
Samsung Medical Center
Singapore General Hospital
Nuffield Hospital
Spire Southampton Hospital
Cancer Sciences Division, Somers Cancer Research Building
Guy's and St Thomas' NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1 (R-CVP)

Arm 2 (R-GDP)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1

DLT was defined as: febrile neutropenia, Grade (Gr) 4 neutropenia ≥7 days, Gr 4 thrombocytopenia ≥7 days, Gr 3/4 thrombocytopenia associated with bleeding requiring a transfusion, Gr 3/4 non-hematologic toxicity (except alopecia) ≥7 days or treatment-related and clinically significant irrespective of duration, ≥Gr 3 QTc prolongation, Gr 4 alanine or aspartate aminotransferase, Gr 2 hyperbilirubinemia (greater than (>)1.5 x upper normal limit) >7 days, delayed recovery from a treatment-related toxicity that prevented re-dosing by >7 days, or Granulocyte-colony stimulating factor treatment during the first cycle.

Participants Reporting DLT AEs for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 2

Percentage of Participants With Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) According to International Response Criteria for NHLs in the MTD and EE Cohorts

OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (less than or equal to [≤]1.5 centimeters [cm] in their greatest transverse diameter (GTD) for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the sum of the product diameters (SPD) of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.

Percentage of Participants With a Treatment Emergent AE

An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event may not necessarily have had a causal relationship with the treatment or usage. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were defined as those occurring on or after the first study drug dose day through and including 56 days post last dose of study drug. The severity of all AEs was graded by the investigator using the National Cancer Institute Common Terminology Criteria for AE Version 3.0 (NCI CTCAE v3.0).

Percentage of Participants With Any Grade 3/4 Chemistry Abnormality During Therapy

The following parameters were analyzed for blood chemistry: blood urea nitrogen (or urea), creatinine, glucose, calcium, sodium, potassium, phosphorus, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, total bilirubin (and direct bilirubin, if total bilirubin was elevated), alkaline phosphatase, uric acid (or urate), albumin and total protein. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals "severe" and CTCAE Grade 4 equals "life threatening or disabling."

Percentage of Participants With Any Grade 3/4 Hematology Abnormality During Therapy

The following parameters were analyzed for hematology: lymphocytes, basophils, eosinophils, erythrocytes, hematocrit, hemoglobin, leukocytes, monocytes, neutrophils, platelets, prothrombin international normalized ratio, prothrombin time, fibrinogen, and activated partial thromboplastin time. Laboratory test results were graded using the NCI CTCAE v3.0 where CTCAE Grade 3 equals "severe" and CTCAE Grade 4 equals "life threatening or disabling."

Secondary Outcome Measures

Percentage of Participants With a Best OR of CR or PR According to International Response Criteria for NHLs in the DE Cohorts

OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their GTD for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.

Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in the DE Cohorts

PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with overall response of CR, PR, stable disease (SD), or disease progression (PD), but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose.

Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the DE Cohorts

Measure includes death from any cause, PD (including symptomatic deterioration) during and after treatment or initiation of new anticancer therapy for the lymphoma. PD was defined as symptomatic deterioration and according to the International Response Criteria for NHL: 1) appearance of any new lesion >1.5 cm in any axis during or at EOT, even if other lesions are decreasing, 2) at least a 50% increase from nadir in the SPD of any previously involved or single involved nodes, or the size of other lesions (splenic or hepatic). Lymph nodes with a short axis diameter of <1.0 cm must increase by ≥50% and to a size of 1.5x1.5 cm or >1.5 cm in the long axis, 3) 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PD was defined as clinical PD, new non-nodal lesions or new nodal lesion ≥1.5 cm in GTD, progression of existing non-index lesions or bone marrow that was negative and now positive.

Kaplan-Meier Estimate of the PFS in the MTD Confirmation/EE Cohorts

PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with OR of CR, PR, SD, or PD, but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose.

Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts.

Kaplan-Meier Estimate of the Overall Survival (OS) in the DE Cohorts

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact.

Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the DE Cohorts

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact.

Kaplan-Meier Estimate of the OS in the MTD Confirmation/EE Cohorts

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact.

Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact.

Mean Inotuzumab Ozogamicin Serum Concentrations

Pharmacokinetic (PK) samples were required for participants enrolled in the confirmatory and preliminary efficacy MTD cohorts only (Parts 2 and 3). Concentrations of inotuzumab ozogamicin in serum were determined using appropriate, validated unconjugated (also known as free) bioanalytical assays.

Full Information

NCT ID

NCT01055496

First Posted

January 21, 2010

Last Updated

June 13, 2019

Sponsor

Pfizer

Collaborators

UCB Pharma

1. Study Identification

Unique Protocol Identification Number

NCT01055496

Brief Title

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

Official Title

AN OPEN-LABEL, PHASE 1 STUDY OF R-CVP OR R-GDP IN COMBINATION WITH INOTUZUMAB OZOGAMICIN IN SUBJECTS WITH CD22-POSTIVE NON-HODGKIN'S LYMPHOMA

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

March 2010 (Actual)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

Collaborators

UCB Pharma

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, B-Cell

Keywords

Non-Hodgkin's lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 (R-CVP)

Arm Type

Experimental

Arm Description

Arm Title

Arm 2 (R-GDP)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

inotuzumab ozogamicin+rituximab +cyclophosphamide+vincristine+prednisone

Other Intervention Name(s)

CMC-544

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

inotuzumab ozogamicin+rituximab+gemcitabine+cisplatinum+dexamethasone

Other Intervention Name(s)

CMC-544

Intervention Description

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.

Primary Outcome Measure Information:

Title

Participants Reporting Dose Limiting Toxicity (DLT) Adverse Events (AEs) for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 1

Description

Time Frame

From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle.

Title

Participants Reporting DLT AEs for Participants in the DE Cohort and the MTD Confirmation Cohort for Arm 2

Description

Time Frame

From the first dose of study medication (Study Day 1) to the completion of the first 21-day cycle.

Title

Percentage of Participants With Best Overall Response (OR) of Complete Response (CR) or Partial Response (PR) According to International Response Criteria for NHLs in the MTD and EE Cohorts

Description

Time Frame

From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks.

Title

Percentage of Participants With a Treatment Emergent AE

Description

Time Frame

SAEs were assessed from informed consent through and including the end of treatment visit (at least 28 calendar days after last study drug administration). Non-SAEs were recorded from time of the first dose of study drug through last participant visit.

Title

Percentage of Participants With Any Grade 3/4 Chemistry Abnormality During Therapy

Description

Time Frame

Within 3 days prior to the start of each cycle, on Day 8 of each cycle, on Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days.

Title

Percentage of Participants With Any Grade 3/4 Hematology Abnormality During Therapy

Description

Time Frame

Within 3 days prior to the start of each cycle, Day 8 of each cycle, Day 15 of Cycles 1, 2, and 3, and the end-of-treatment visit. Each Cycle is 21 Days.

Secondary Outcome Measure Information:

Title

Percentage of Participants With a Best OR of CR or PR According to International Response Criteria for NHLs in the DE Cohorts

Description

OR was evaluated according to the International Response Criteria for NHLs. CR was defined as complete disappearance of all lesions and disease-related symptoms; all nodes must have decreased to normal (≤1.5 cm in their GTD for nodes >1.5 cm before therapy) or ≤1 cm (short axis) in previously involved node; enlarged spleen prior to therapy must have regressed and be non-palpable; bone marrow lymphoma: infiltrate must have been cleared on repeat bone marrow aspirate and biopsy. PR was defined as >50% decrease in the SPD of up to 6 index lesions. No increase in size of other nodes, liver or spleen. Splenic and hepatic nodules must have regressed by ≥50% in the SPD or GTD (for single nodules). With the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. No progression of non-target disease or new lesions.

Time Frame

From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks.

Title

Kaplan-Meier Estimate of the Progression-Free Survival (PFS) in the DE Cohorts

Description

Time Frame

From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks

Title

Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the DE Cohorts

Description

Time Frame

6, 12 and 24 months

Title

Kaplan-Meier Estimate of the PFS in the MTD Confirmation/EE Cohorts

Description

PFS was defined as time from date of first dose to the earlier date of progression (including symptomatic deterioration), date of death from any cause, or initiation of new anticancer therapy for the lymphoma. Participants without an event were censored at the date of the last valid tumour assessment. A valid tumour assessment visit was defined as the tumour assessment visit with OR of CR, PR, SD, or PD, but not 'Not Done' or 'Unknown'. Participants without a post-baseline tumour assessment and without a PFS event were censored on the date of first dose.

Time Frame

From first dose of study medication through 2 year follow-up period, including but not limited to planned assessments scheduled every 9 to 24 weeks

Title

Kaplan-Meier Estimates of the Probability of Being Alive and Free From PD or New Anticancer Therapy at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts.

Description

Time Frame

6, 12, and 24 months

Title

Kaplan-Meier Estimate of the Overall Survival (OS) in the DE Cohorts

Description

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact.

Time Frame

From first dose of study medication through 2 year follow-up period

Title

Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the DE Cohorts

Description

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact.

Time Frame

6, 12, and 24 months

Title

Kaplan-Meier Estimate of the OS in the MTD Confirmation/EE Cohorts

Description

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact.

Time Frame

From first dose of study medication through 2 year follow-up period

Title

Kaplan-Meier Estimates of the Probability of Being Alive at 6, 12, and 24 Months in the MTD Confirmation/EE Cohorts

Description

OS was defined from date of first dose to date of death due to any cause, censoring at the date of last contact.

Time Frame

6, 12, and 24 Months

Title

Mean Inotuzumab Ozogamicin Serum Concentrations

Description

Time Frame

Pre-dose on Cycle 1, Day 2; Pre-dose, 1 and 3 hours post-dose on Cycle 3, Day 2; 24 hours post-dose on Cycle 3, Day 3 and 168 hours post-dose on Cycle 3, Day 8.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Davis Cancer Pavillion and Shands Medical Plaza

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Facility Name

Shands Cancer Hospital At The University Of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Facility Name

Shands Hospital at the University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Fox Chase Cancer Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111-2497

Country

United States

Facility Name

The University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030-4009

Country

United States

Facility Name

Northwest Medical Specialties, PLLC

City

Federal Way

State/Province

Washington

ZIP/Postal Code

98003

Country

United States

Facility Name

Northwest Medical Specialties, PLLC

City

Gig Harbor

State/Province

Washington

ZIP/Postal Code

98332

Country

United States

Facility Name

Northwest Medical Specialties, PLLC

City

Lakewood

State/Province

Washington

ZIP/Postal Code

98499

Country

United States

Facility Name

Rainier Physicians, PC

City

Puyallup

State/Province

Washington

ZIP/Postal Code

98373

Country

United States

Facility Name

Northwest Medical Specialties PLLC

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

UZ Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

UZ Gasthuisberg

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Cross Cancer Institute

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Queen Elizabeth Health Sciences Centre

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Princess Margaret Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Hospital Saint-Louis - Service d'Hemato-Oncologie

City

Paris Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

Hopital Saint-Louis -Universite Paris VII

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

Centre Hospitalier Lyon Sud - Service d'Hematologie

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Facility Name

Prince of Wales Hospital

City

Hong Kong

Country

Hong Kong

Facility Name

Nagoya Daini Red Cross Hospital

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

466-8650

Country

Japan

Facility Name

National Cancer Center Hospital

City

Chuo-ku

State/Province

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Cancer Institute Hospital, Japanese Foundation For Cancer Research

City

Koto-Ku

State/Province

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Singapore General Hospital

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

Facility Name

Nuffield Hospital

City

Eastleigh

State/Province

Hants

ZIP/Postal Code

SO53 2DW

Country

United Kingdom

Facility Name

Spire Southampton Hospital

City

Southampton

State/Province

Hants

ZIP/Postal Code

SO16 6UY

Country

United Kingdom

Facility Name

Cancer Sciences Division, Somers Cancer Research Building

City

Southampton

State/Province

Hants

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Guy's and St Thomas' NHS Foundation Trust

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Citations:

PubMed Identifier

28959500

Citation

Sangha R, Davies A, Dang NH, Ogura M, MacDonald DA, Ananthakrishnan R, Paccagnella ML, Vandendries E, Boni J, Goh YT. Phase 1 study of inotuzumab ozogamicin combined with R-GDP for the treatment of patients with relapsed/refractory CD22+ B-cell non-Hodgkin lymphoma. J Drug Assess. 2017 Aug 16;6(1):10-17. doi: 10.1080/21556660.2017.1315336. eCollection 2017.

Results Reference

derived

PubMed Identifier

27154915

Citation

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. doi: 10.1158/1078-0432.CCR-15-2488. Epub 2016 May 6.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3129K2-1105&StudyName=Study%20Evaluating%20Chemotherapy%20in%20Combination%20With%20Inotuzumab%20Ozogamicin%20In%20Subjects%20With%20Non-Hodgkin%27s%20Lymphoma

Description

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

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