Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

A Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

Protocol: OSU-15070

Full Title

A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined with MOR00208 in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)

Purpose

This is an open-label, multicentre study to characterize the safety and efficacy of the

human anti CD19 antibody MOR00208 in combination with Lenalidomide in adult subjects with

relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL) who have had at least one, but no

more than three prior systemic regimens and who are not eligible for high dose chemotherapy

(HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.

Are you eligible?

Inclusion Criteria:

Major Inclusion Criteria:

1. Age >18 years

2. Histologically confirmed diagnosis of DLBCL

3. Tumour tissue for central pathology review and correlative studies must be provided.

4. Patients must have:

relapsed and/or refractory disease

at least one bidimensionally measurable, PET positive disease site (transverse

diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)

received at least one, but no more than three previous systemic regimens for the

treatment of DLBCL and one therapy line must have included a CD20-targeted

therapy

Eastern Cooperative Oncology Group 0 to 2

5. Patients not considered in the opinion of the investigator eligible, or patients

unwilling to undergo intensive salvage therapy including ASCT

6. Patients must meet the following laboratory criteria at screening:

absolute neutrophil count ≥1.5 × 109/L

platelet count ≥90 × 109/L

total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or

liver involvement by lymphoma

alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 ×

ULN or <5 × ULN in cases of liver involvement

serum creatinine clearance ≥60 mL/minute

7. Females of childbearing potential (FCBP) must:

not be pregnant

refrain from breastfeeding and donating blood or oocytes

agree to ongoing pregnancy testing

commit to continued abstinence from heterosexual intercourse, or agree to use

and be able to comply with the use of double-barrier contraception

8. Males (if sexually active with a FCBP) must

use an effective barrier method of contraception

refrain from donating blood or sperm

9. In the opinion of the investigator the patients must:

be able and willing to receive adequate prophylaxis and/or therapy for

thromboembolic events

be able to understand the reason for complying with the special conditions of

the pregnancy prevention risk management plan and give written acknowledgement

of this.

Major Exclusion Criteria:

1. Patients who have:

other histological type of lymphoma

primary refractory DLBCL

a history of "double/triple hit" genetics

2. Patients who have, within 14 days prior to Day 1 dosing:

not discontinued CD20-targeted therapy, chemotherapy, radiotherapy,

investigational anticancer therapy or other lymphoma specific therapy

undergone major surgery or suffered from significant traumatic injury

received live vaccines.

required parenteral antimicrobial therapy for active, intercurrent infections

3. Patients who:

were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide,

LEN)

have undergone ASCT within the period ≤ 3 months prior to signing the informed

consent form.

have undergone previous allogenic stem cell transplantation

have a history of deep venous thrombosis/embolism and who are not willing/able

to take venous thromboembolic event prophylaxis during the entire treatment

period

concurrently use other anticancer or experimental treatments

4. Prior history of malignancies other than DLBCL, unless the patient has been free of

the disease for ≥5 years prior to screening.

5. Patients with:

positive hepatitis B and/or C serology.

known seropositivity for or history of active viral infection with human

immunodeficiency virus (HIV)

CNS lymphoma involvement

history or evidence of clinically significant cardiovascular, CNS and/or other

systemic disease that would in the investigator's opinion preclude participation

in the study or compromise the patient's ability to give informed consent.

Exclusion Criteria:

Major Inclusion Criteria:

1. Age >18 years

2. Histologically confirmed diagnosis of DLBCL

3. Tumour tissue for central pathology review and correlative studies must be provided.

4. Patients must have:

relapsed and/or refractory disease

at least one bidimensionally measurable, PET positive disease site (transverse

diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)

received at least one, but no more than three previous systemic regimens for the

treatment of DLBCL and one therapy line must have included a CD20-targeted

therapy

Eastern Cooperative Oncology Group 0 to 2

5. Patients not considered in the opinion of the investigator eligible, or patients

unwilling to undergo intensive salvage therapy including ASCT

6. Patients must meet the following laboratory criteria at screening:

absolute neutrophil count ≥1.5 × 109/L

platelet count ≥90 × 109/L

total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or

liver involvement by lymphoma

alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 ×

ULN or <5 × ULN in cases of liver involvement

serum creatinine clearance ≥60 mL/minute

7. Females of childbearing potential (FCBP) must:

not be pregnant

refrain from breastfeeding and donating blood or oocytes

agree to ongoing pregnancy testing

commit to continued abstinence from heterosexual intercourse, or agree to use

and be able to comply with the use of double-barrier contraception

8. Males (if sexually active with a FCBP) must

use an effective barrier method of contraception

refrain from donating blood or sperm

9. In the opinion of the investigator the patients must:

be able and willing to receive adequate prophylaxis and/or therapy for

thromboembolic events

be able to understand the reason for complying with the special conditions of

the pregnancy prevention risk management plan and give written acknowledgement

of this.

Major Exclusion Criteria:

1. Patients who have:

other histological type of lymphoma

primary refractory DLBCL

a history of "double/triple hit" genetics

2. Patients who have, within 14 days prior to Day 1 dosing:

not discontinued CD20-targeted therapy, chemotherapy, radiotherapy,

investigational anticancer therapy or other lymphoma specific therapy

undergone major surgery or suffered from significant traumatic injury

received live vaccines.

required parenteral antimicrobial therapy for active, intercurrent infections

3. Patients who:

were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide,

LEN)

have undergone ASCT within the period ≤ 3 months prior to signing the informed

consent form.

have undergone previous allogenic stem cell transplantation

have a history of deep venous thrombosis/embolism and who are not willing/able

to take venous thromboembolic event prophylaxis during the entire treatment

period

concurrently use other anticancer or experimental treatments

4. Prior history of malignancies other than DLBCL, unless the patient has been free of

the disease for ≥5 years prior to screening.

5. Patients with:

positive hepatitis B and/or C serology.

known seropositivity for or history of active viral infection with human

immunodeficiency virus (HIV)

CNS lymphoma involvement

history or evidence of clinically significant cardiovascular, CNS and/or other

systemic disease that would in the investigator's opinion preclude participation

in the study or compromise the patient's ability to give informed consent.

Non-Hodgkin’s Lymphoma (B- & T-Cell) Lymphoma