Is NCT07001384 recruiting in Commack, NY?

Yes, NCT07001384 is currently recruiting participants at its Commack, NY location. This anaplastic lymphoma kinase clinical trial is actively enrolling qualified participants.

How do I join the anaplastic lymphoma kinase clinical trial in Commack?

To join this clinical trial in Commack, 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 Commack 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.

Anaplastic Lymphoma Kinase Clinical Trial in Commack, NY

About This Anaplastic Lymphoma Kinase Study in Commack

The researchers are doing this study to see if alectinib in combination with duvelisib is a safe and effective time-limited treatment for people with relapsed or refractory ALK+ anaplastic large cell lymphoma (ALCL). The researchers will test different doses of the study drugs to find the highest doses that cause few or mild side effects in participants. Once they find this dose combination, they will test it in a new group of participants to learn how long the effect of the combination lasts after the end of treatment

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

Inclusion Criteria

Pathologically-confirmed diagnosis of ALK+ ALCL by WHO/ICC, classification procedures in use at the time of diagnosis. Note that ALK+ ALCL by definition expresses ALK, which is readily detectable on standard IHC. Confirmation through molecular sequencing of the specific ALK translocation and fusion partner is not necessary for enrollment.

Relapsed or refractory disease after at least one line of prior systemic therapy.

NOTE: Prior systemic therapy must have included at least one cytotoxic chemotherapy agent.

NOTE: Prior treatment with an ALK inhibitor is allowed.

NOTE: Patients being treated with an ALK inhibitor immediately prior to enrollment are eligible. This includes patients on an ALK inhibitor who are in clinical remission at the time of enrollment, as long as the patient is not immediately planned for allogeneic transplant.

NOTE: If the last therapy was an ALK inhibitor, the patient must not have stopped the ALK inhibitor and maintained clinical remission (no relapse) with no intervening therapy for ≥ six months.

NOTE: Prior progression on ALK inhibitor is not specifically

Exclusion Criteria

ary though should be reviewed with the MSK Principal Investigator.

Age ≥ 18 years at the time of enrollment

ECOG performance status ≤ 2 at the time of enrollment.

Laboratory criteria:

Absolute neutrophil count ≥ 1.0 K/mcL or ≥ 0.5 K/mcL if due to lymphoma (NOTE: growth factor is allowed).

Platelet count ≥ 75 K/uL.

Calculated creatinine clearance ≥ 60 mL/min by Cockcroft-Gault.

Total bilirubin ≤ 2x upper limit of normal (ULN) or ≤ 3x ULN if due to hepatobiliary involvement with lymphoma, or ≤ 3x ULN if history of Gilbert's disease.

Aspartate (AST) and alanine (ALT) aminotransferase ≤ 3 x ULN or ≤ 5x ULN if due to hepatobiliary involvement with lymphoma.

NOTE: Patients with AST and/or ALT \> 3x ULN and total bilirubin \> 2x ULN must be reviewed with the MSK Principal Investigator to determine eligibility.

NOTE: Patients must meet laboratory criteria prior to initiation of the alectinib lead-in cycle and prior to initiation of combination therapy with duvelisib

Able to swallow pills.

Able to take prophylactic medications against Pneumocystis jirovecii pneumonia (PJP)

Women of reproductive potential must have a negative serum or urine β human chorionic gonadotropin (β-HCG) pregnancy test within 14 days before initiating therapy.

Females of childbearing age must be on effective contraception per institutional standards during the treatment period and for 5 weeks after the last dose of the study drugs.

Males must consistently use an effective contraception method per institutional standards during the treatment period and for 3 months following the last dose of the study drugs. Exclusion Criteria:

Prior allogeneic stem cell transplant within 6 months of starting treatment or patients with active graft versus host disease (GVHD). o NOTE: Prior allogeneic stem cell transplant may be allowed after discussion with MSK PI if no GVHD or immunosuppression is present at time of enrollment.

Previous systemic anti-cancer therapy for ALK+ ALCL within 7 days of initiating study drug

NOTE: Systemic corticosteroids are allowed and must be tapered to 10 mg/day or less (prednisone equivalent) upon start of investigational treatment.

NOTE: Patients who have received localized radiotherapy as part of immediate prior therapy may be allowed to enroll with shorter washout period after discussion with the MSK Principal Investigator.

NOTE: Prior progression on ALK inhibitor is not specifically exclusionary though should be reviewed with the MSK Principal Investigatory.

Ongoing use of immunosuppressant medications, including corticosteroids greater than 10 mg of prednisone or equivalent at the time of enrollment.

Prior gastrointestinal condition or surgery that may, in the investigator's judgment, adversely affect drug absorption.

Active viral infection with hepatitis B or hepatitis C. For hepatitis B, patients who are seropositive (hepatitis B core Ab positive) are permitted if HBV DNA is negative by PCR. For hepatitis C, patients who are seropositive (hepatitis C Ab positive) are eligible if HCV DNA is negative by PCR and curative therapy has been completed. o NOTE: Patients with HIV infection are permitted to enroll but are required to be on antiretroviral regimens that are in accordance with the current International AIDS Society guidelines on concurrent use with chemotherapy. Use of experimental antiretroviral agents or those containing zidovudine or ritonavir, cobicistat or similar potent CYP3 inhibitors are prohibited. In order to be eligible, patients taking zidovudine or ritonavir, or cobicistat or other CYP3 inhibitors must change to a different regimen 7 days prior to therapy initiation. Subjects must be on HAART for at least 12 weeks prior to therapy.

Concurrent malignancy requiring active therapy within the last 2 years with the exception of basal cell or squamous cell carcinoma limited to the skin, carcinoma in situ of the cervix, breast or localized prostate cancer. Adjuvant or maintenance therapy to reduce the risk of recurrence or other malignancy is permissible after discussion with the Principal Investigator.

Active cytomegalovirus (CMV) as defined by positive CMV PCR with clinical manifestations consistent with active CMV infection and requiring therapy. Carriers will be managed as per institutional guidelines.

Patients should not be on CYP4503A inhibitors or inducers at the time of treatment initiation.

Pregnant or breastfeeding women.

Any serious or unstable medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing informed consent or, in the investigator's judgment, increase the risk to the patient associated with participation in the study

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 Commack?

Yes, this clinical trial (NCT07001384) has an active research site in Commack, NY 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.

Anaplastic Lymphoma Kinase Treatment Options in Commack, NY

If you're searching for anaplastic lymphoma kinase treatment options in Commack, NY, this clinical trial (NCT07001384) 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 Commack research site is actively enrolling participants for this clinical trial. You'll receive care from experienced anaplastic lymphoma kinase 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 anaplastic lymphoma kinase clinical trials near you to find additional studies recruiting in your area.

Anaplastic Lymphoma Kinase Clinical Trial in Commack, NY

Expert Care in Commack

IRB Approved

No-Cost Care

Apply for This Commack Location

Why Participate?

Simple Process