CLINICAL TRIAL / NCT05019976
Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
- Interventional
- Recruiting
- NCT05019976
Contact Information
An i3+3 Phase I Dose-per-Fraction Escalation Trial for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma
This study focuses on using shortened courses of radiation for participants with relapsed/refractory Hodgkin/Non-Hodgkin lymphoma. Treatment radiation over 5-6 weeks is often standard of care for many people with lymphoma, but doctors leading this study aim to find out if using radiation for a shorter period of time can be safe for treating lymphoma and if so, what is the safest shortened dose of radiation for participants.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
INCLUSION CRITERIA:
1. Signed Written Informed Consent:
- Participants must be able to give self-consent and then sign and date an
Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved
written informed consent in accordance with local regulatory and institutional
guidelines. This consent must be obtained before the performance of any
protocol-related procedures that are not considered part of normal participant
care.
- Participants must be willing and able to comply with scheduled visits,
treatment schedule, laboratory testing, and other requirements of the study.
2. Must have the following disease/participant characteristics:
- Men or women ≥ 18 years of age.
- Must have clinically confirmed relapsed/refractory Hodgkin/non-Hodgkin lymphoma
- Mush have undergone appropriate standard of care treatment options (in the
opinion of the treating investigator).
- Must have measurable disease/tumors as defined by RECIST Version 1.1, including
at least one tumor lesion that meets criteria for radiation (0.25 cc to 65 cc
of viable tumor approximately 5 cm in maximal dimension). Tumors larger than 65
cc can be partially treated but the whole tumor should receive at least the
minimal prescribed dose.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance
status of ≤ 2
- Must have adequate organ function, as defined by clinical lab values provided
to the study doctor.
- Must have an doctor-determined life expectancy of at least 1 month.
- Participants who are women of childbearing potential (WOCBP) must have a
negative serum or urine pregnancy test within 72 hours prior to the start of
study.
- Participants who are women must not be breastfeeding.
- Participants who are WOCBP must agree to follow instructions for method(s) of
contraception for the duration of treatment with study drug(s) and up to 5
months post last dose of study drug(s).
- Participants who are WOCBP who are continuously not heterosexually active are
exempted from contraceptive requirements but still must undergo pregnancy
testing as described in this section.
- Participants who are males and who are sexually active with WOCBP must agree to
follow instructions for method(s) of contraception for the duration of
treatment with study drug(s) and up to 7 months post last dose of study
drug(s). In addition, male participants must be willing to refrain from sperm
donation during this time.
- Participants who are azoospermic males (males who dont ejaculate without sperm)
are exempt from contraceptive requirements.
- Study doctors shall counsel WOCBP, and male participants who are sexually
active with WOCBP, on the importance of pregnancy prevention and the
implications of an unexpected pregnancy. Investigators shall advise on the use
of highly effective methods of contraception, which have a failure rate of < 1%
when used consistently and correctly.
EXCLUSION CRITERIA:
- Participants must not have an indolent lymphoma or other type of lymphoma which
could be effectively treated with radiation doses substantially less then and EQD2
of 50 Gy
- Participants must not receive concurrent chemotherapy, targeted small molecule
therapy, radiation or other anti-cancer therapy (with exceptions for
disease-specific hormone treatments considered standard of care), anti-cancer
monoclonal antibody (mAb) or have not recovered (i.e. < grade 1 or at baseline) from
adverse events due to a previously administered agent. Participants may receive
concurrent steroids.
i) Note: subjects with < grade 2 neuropathy are an exception to this criterion and
may qualify for the study.
ii) Note: if subject received major surgery, they must have recovered adequately from the
toxicity and/or complications from the intervention prior to starting therapy.
iii) Note: subjects with any grade alopecia are an exception to this criterion and may
qualify for the study
- Participants must not have had prior radiation therapy (defined as >10% of prior
prescription dose) to the area planning to be treated with radiation.
- Participants who have had prior cytotoxic chemotherapy must not receive that therapy
within 2 weeks of the initiation of radiation
- Participants who have had prior anti-cancer monoclonal antibody (mAb) or other small
molecules must not receive that therapy within 7 days of the initiation of radiation
- Participants must not have a known additional malignancy that could confuse analysis
of on-study treatment. Inclusion of all study participants with more than one
malignancy must be discussed and approved by the PI.
- Participants must not have a known history of non-infectious pneumonitis that
required steroids for treatment.
- Participants must not have evidence of interstitial lung disease.
- Participants must not have a current seizure disorder.
- Participants must not have a history or current evidence of any condition, therapy
or laboratory abnormality that might confound the results of the trial, interfere
with the subject's participation for the full duration of the trial, or is not in
the best interest of the subject to participate, in the opinion of the treating
investigator.
- Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the screening visit through 120 days
after the last dose of trial treatment.
- If known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
[qualitative] is detected) then patient is not eligible for treatment of liver
lesions
- Participants must not have had uncontrolled or significant cardiovascular disease
including, but not limited to, any of the following:
- Myocardial infarction or stroke/transient ischemic attack within the past 6
months
- Uncontrolled angina within the past 3 months
- Any history of clinically significant arrhythmias (such as ventricular
tachycardia, ventricular fibrillation, or torsades de pointes)
- History of other clinically significant heart disease (e.g. cardiomyopathy,
congestive heart failure with New York Heart Association functional
classification III to IV, pericarditis, significant pericardial effusion, or
myocarditis)
- Cardiovascular disease-related requirement for daily supplemental oxygen
therapy.
- Participants may not concomitantly use statins while on study. However, a patient
using statins for over 3 months prior to study drug administration and in stable
status without CK rise may be permitted to enroll.
- Participants may not have current or history of clinically significant muscle
disorders (e.g. myositis), recent unresolved muscle injury, or any condition known
to elevate serum CK levels.
- Participants must not be prisoners or be involuntarily incarcerated.
- Participants must not be compulsorily detained for treatment of either a psychiatric
or physical (e.g., infectious disease) illness.