Is NCT06768905 recruiting in Dallas, TX?

Yes, NCT06768905 is currently recruiting participants at its Dallas, TX location. This non hodgkin lymphoma clinical trial is actively enrolling qualified participants.

How do I join the non hodgkin lymphoma clinical trial in Dallas?

To join this clinical trial in Dallas, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Dallas clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Non Hodgkin Lymphoma Clinical Trial in Dallas, TX

About This Non Hodgkin Lymphoma Study in Dallas

This study is being done to determine the safety, efficacy and tolerability of a single 50 mCi dose of 131I-Apamistamab given prior to FDA approved (commercially available) infusion in patients with Relapsed or refractory (R/R) non-Hodgkin lymphoma.

Sponsor: University of Texas Southwestern Medical Center

Who Can Participate

Inclusion Criteria

Patients with diffuse large B-cell lymphoma (de novo or DLBCL transformed from an indolent lymphoma (follicular lymphoma, chronic lymphocytic leukemia \[Richter syndrome\]) or high-grade B-cell lymphoma (HGBL): ("DLBCL patients")

Defined as relapsed or refractory DLBCL or high-grade B-cell lymphoma (HGBL) following at least one or more prior chemoimmunotherapy regimen (with at least one course including an anthracycline and CD20-directed therapy) following diagnosis of de novo DLBCL/HGBL or DLBCL arising from indolent lymphoma and requiring further treatment and deemed to be candidates for standard of care CAR-T therapy. This includes patients with primary refractory disease (failure to achieve complete response (CR) to first-line therapy), relapsed disease within 12 months of first line chemoimmunotherapy or relapsed/refractory disease after 2 or more prior lines of systemic therapy.

Relapsed or refractory disease must be confirmed with a repeat biopsy within the last 12 months.

Age ≥ 18 years of age

Creatinine clearance ≥50 mL/min as calculated by the Cockroft-Gault formula.

Total bilirubin ≤1.5x upper limit of normal , AST and ALT ≤3x upper limit of normal (ULN), unless liver dysfunction is thought to be related to underlying malignancy or secondary to Gilbert's disease in which case the direct bilirubin should be ≤3.0 mg/dL, and AST and ALT ≤5x ULN.

Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air or per institutional guidelines.

Thyroid function tests (TSH, FT4) ≤2x upper limit of normal (ULN)

Adequate bone marrow function meeting the following criteria as defined below, without requiring blood product or granulocyte-colony stimulating factor support in the 7 days prior to screening and start of 131I-Apamistamab treatment.

Absolute neutrophil count ≥1.0k/µL,

Platelets ≥50k/µL,

Hemoglobin ≥8g/dL.

Performance status: ECOG performance status 0-2.

All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, and/or abstinence) prior to study entry, and for the duration of study treatment, and for 30 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

Has not undergone a hysterectomy or bilateral oophorectomy; or

Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

Ability to understand and the willingness to sign a written informed consent.

For patients undergoing bridging therapy after leukapheresis and prior to 131I-Apamistamab infusion a repeat PET or CT scan will be performed 10-14 days prior to the 131I-Apamistamab infusion. They will also be required to meet inclusion criteria number 1 and 7 above within 10-14 days prior to the planned infusion of 131I-Apamistamab. This will be considered eligibility Screening 2 and will be approved by the Sponsor-Investigator.

Exclusion Criteria

Pregnant or lactating patients.

Impaired cardiac function (LVEF \<40%) as assessed by echocardiogram or MUGA scan.

Patients with active graft versus host disease following allogeneic hematopoietic cell transplantation requiring systemic T-cell suppressive therapy are ineligible.

Patients with active autoimmune disease requiring systemic T-cell suppressive therapy are ineligible.

Patients with the following cardiac conditions will be excluded:

New York Heart Association (NYHA) stage III or IV congestive heart failure

Myocardial infarction ≤6 months prior to enrollment

Any history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration.

Have current or prior positive test results for human immunodeficiency virus (HIV) or hepatitis B (HBV) or C (HCV), with the following exceptions:

Patients who have positive HBV test results due to having been previously vaccinated against hepatitis B, as evidenced by negative hepatitis B surface antigen (HbsAg), negative anti- hepatitis B core protein (HBc) and positive antibody to the HbsAg (anti-HBs) are not excluded.

Patients who have antibodies to HCV or who have hepatitis B core antibody, with undetectable viremia by PCR, and with adequate organ function as defined in the protocol, are not excluded.

Patients with uncontrolled systemic fungal, bacterial, viral, or other infections are ineligible.

Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin.

Patients with history or presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, severe brain injuries are ineligible.

Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.

Patients with circulating human anti-mouse antibodies (HAMA) to BC8. The results of HAMA testing will need to be available prior to 131I-Apamistamab infusion.

Patients with prior history of treatment with radiopharmaceuticals for lymphoma treatment indication.

Patients with QTcF \>470mSec on EKG

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Dallas?

Yes, this clinical trial (NCT06768905) has an active research site in Dallas, TX that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Non Hodgkin Lymphoma Treatment Options in Dallas, TX

If you're searching for non hodgkin lymphoma treatment options in Dallas, TX, this clinical trial (NCT06768905) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Dallas research site is actively enrolling participants for this clinical trial. You'll receive care from experienced non hodgkin lymphoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all non hodgkin lymphoma clinical trials near you to find additional studies recruiting in your area.

Non Hodgkin Lymphoma Clinical Trial in Dallas, TX

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